MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/PFNA BLADE; EXTRACTOR

Catalog Number 03.010.411

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information is not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa explant date: portion of the device is still implanted in the patient.Initial reporter's phone number: (b)(6).The complainant indicated that the extraction screw is stuck in the implanted blade and the blade was unable to be explanted.Therefore, a non-implant grade fragment is retained in the patient.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #03.010.411 / lot #7744954.Manufacturing location: (b)(4).Manufacturing date: 21.Feb.2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the nurse called the sales rep on (b)(6) 2017 and told him that they have problems during the surgery.They were about to remove a proximal femoral antirotation blade (pfna) and had accidently used a wrong guide wire and when the used the extraction screw, the tip broke into the pfna blade.The blade could not be removed, and they tried to get it out.The sales rep suggested to organize an instrument set for pfna blade removal but the nurse said that this would take too long time.The nurse would talk to the surgeon, and would return if they needed the instrument set for pfna blade removal.The sales rep did not heard from them.The surgery was prolonged to an unknown time.No information available about patient condition and outcome.It was reported that the patient had post-operativey pain and thought this was because of the implanted proximal femoral antirotation (pfna) implants (b)(4).They could not remove the implant, and have closed the site, and will now plan and order instrument for removal of damaged pfna blade.The blade is still in the patient.The broken off piece of the extraction screw is stuck in the implanted blade.The surgery was not successfully completed.This complaint involves 2 parts.Concomitant reported parts: 1x unknown guide wire (ø 2,5 or 2,8 mm).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Complained device was received and forwarded to the manufacturing site for investigation.As received condition of device: the instrument was not delivered in the original packaging.Laser marking was readable.The piece generated from the breakage was not delivered for investigation; is missing.The piece with the thread m7x1 lh and hexagon on it, is (as indicated in the complaint description) still in the implanted blade ¿the broken off piece of the extraction screw is stuck in the implanted blade.¿ a dhr check was performed for the affected product 03.010.411 lot 7744954.The dhrs were reviewed and no issue or deviation, neither ncs were found which could lead to the complaint condition.As relevant for the complaint condition; ¿the tip of the extract screw was broken, and is still in the implanted blade¿ the position, the inner diameter as well as the hardness were identified and measured.All features measured are according to the drawing and have passed the specification through the gauges.As this instrument is broken, the hardness was also measured, specifically on the diameter ø11.4 as close as possible to the region broken; the results show that has passed its manufacturing specifications.The hardness was also tested during manufacturing process through the inspection sheet as well as through a protocol from a supplier ¿härterei schmid ag¿.Besides, during the manufacturing process, the features m7x1 lh and hex 4.5 were inspected 100% and documented according to the inspection sheet, and the whole lot size has passed its specifications; no deviations neither scrap was detected.The lots of the raw material 60063691 of the component (b)(4) are not tracked by a lot number.Therefore, the check was performed based on fifo (first in/first out) by investigation of the raw material orders, which was closest to the start of the manufacturing order of the component.Thus, the raw material used fulfilled the specifications.This complaint is confirmed since the instrument is broken as claimed by the customer.However, according to the investigation results and from the manufacturing point of view this complaint is rated as not valid because the relevant dimensions were measured and have passed the specifications and no manufacturing issue could be found in the results neither in the manufacturing documentation reviewed (dhr, material certificate, etc.).As this complaint is not valid therefore the review of the specific prm and pra line is not applicable.Device is an instrument and is not implanted/explanted.G5: device is not distributed in the united states, but is similar to device marketed in the usa.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device history lot: 03.010.411.Lot 7744954.Manufacturing location: (b)(4).Manufacturing date: 21.Feb.2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition a manufacture review was conducted: investigation summary: the investigation of the extraction screw 03.010.411 was already performed in etq under complaint (b)(4), mia-(b)(4), here the investigation result.As received condition of device: the instrument was not delivered in the original packaging.Laser marking was readable.The piece generated from the breakage was not delivered for investigation; is missing.The piece with the thread m7x1 lh and hexagon on it, is (as indicated in the complaint description) still in the implanted blade ¿the broken off piece of the extraction screw is stuck in the implanted blade.¿ the "investigation summary" is a conclusion from the attached document(s).A dhr check was performed for the affected product 03.010.411 lot 7744954 work order (b)(4) and component (b)(4) / work order (b)(4).The dhrs were reviewed and no issue or deviation, neither ncs were found which could lead to the complaint condition.The component article was not checked because they are not relevant to the complaint condition.As relevant for the complaint condition; ¿the tip of the extract screw was broken, and is still in the implanted blade¿ the position, the inner diameter as well as the hardness were identified and measured.All features measured are according to and have passed the specification through the gauges.As this instrument is broken, the hardness was also measured, specifically on the diameter as close as possible to the region broken; the results show that has passed its manufacturing specifications: the hardness was also tested during manufacturing process through the inspection sheet as well as through a protocol from a supplier ¿härterei schmid ag¿.Besides, during the manufacturing process, the features m7x1 lh and hex 4.5 were inspected 100% and documented according to the inspection sheet, and the whole lot size has passed its specifications; no deviations neither scrap was detected.The lots of the raw material of the component are not tracked by a lot number.Therefore, the check was performed based on fifo (first in/first out) by investigation of the raw material orders, which was closest to the start of the manufacturing order of the component.Thus, the raw material used fulfilled the specifications.This complaint is confirmed since the instrument is broken as claimed by the customer.However, according to the investigation results and from the manufacturing point of view this complaint is rated as not valid because the relevant dimensions were measured and have passed the specifications and no manufacturing issue could be found in the results neither in the manufacturing documentation reviewed (dhr, material certificate, etc.).As this complaint is not valid therefore the review of the specific prm and pra line is not applicable.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: complaint re-opened photo's received for investigation.

Manufacturer Narrative

Corrected data: corrected device returned to manufacturer date.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Concomitant device list.Upon receipt of the products,previously reported concomitant device unknown guide wire is now determined as the reportable device and not a concomitant device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The hook sticking to the blade happened when the blade removal tool was used to get the blade out.This event is reported under linked complaint (b)(4).Concomitant device reported: pfna ø10 long le 130° l340 tan (part # 472.325s, lot # 9722611, quantity 1).This is report 1 of 3 for complaint (b)(4).

• Brand Name: EXTRACTSCR F/PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6966805
• MDR Text Key: 89925569
• Report Number: 9612488-2017-10535
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819349483
• UDI-Public: (01)07611819349483(10)7744954
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 7744954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 03/12/2018; 05/18/2018; 05/22/2018
• Supplement Dates FDA Received: 11/16/2017; 04/04/2018; 05/18/2018; 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR