MAUDE Adverse Event Report: SYNTHES HAGENDORF CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 03.010.000

Device Problem Material Distortion (2977)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: patient was implanted with the external tibial nail for a tibia fracture on (b)(6) 2016.Patient was returned to surgery on (b)(6) 2017 for removal of same.During the removal procedure, after surgeon had extracted all other screws, the hammer guide and the slide hammer were threaded into the extraction screw.It was at that point it was noted the hammer guide was distorted, causing the slide hammer to not slide smoothly.As a result, the nail could not be extracted.Surgery was delayed approximately 60 minutes.It has not been determined if a revision surgery will be scheduled in the future.Patient outcome reported as good, surgery was not completed successfully as the nail remains implanted.Concomitant devices reported: extraction screw (03.010.100, lot unknown, quantity 1), slide hammer (03.010.056, lot unknown, quantity 1), tibia nail (part unknown, lot unknown, quantity 1), blade (part unknown, lot unknown, quantity 1) this report is for one (1) radiolucent drill bit.This is report 2 of 2 for com-(b)(4).

Manufacturer Narrative

Device returned to manufacturer.A device history record (dhr) review was performed on part # 03.010.000, lot # 3206217: manufacturing location: (b)(4), manufacturing date: 09.July 2009: no non conformance reports (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.Upon return of the devices it has been determined that the initially reported concomitant devices extraction screw (part # 03.010.100) and blade are no longer considered concomitant devices.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

Concomitant medical products: screws (part # unknown, lot # unknown, quantity unknown).

Manufacturer Narrative

A product investigation was completed: the returned parts show visual signs of wear and tear.Based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.Hammer guide (part 357.220): there are hammer blow marks and scratches on the device.The laser etching is not readable.The manufacturing review could not be performed because of missing lot number.We are not able to determine the exact cause of this occurrence due to missing detailed clinical information.The hammer guide is not bent as indicated in the complaint description.Based on this the complaint will be rated as unconfirmed.Due to the condition of the device it is likely that this device was often and intensive used.A functional check was performed with received slide hammer with the result that device is functional as intended.Conical extraction screw (part 03.010.000): there are scratches and marks everywhere on the device's surface.The thread is damaged.The laser etching is not readable.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.We are not able to determine the exact cause of this occurrence due to missing detailed clinical information.It is likely that a mechanical overload situation during use led to the damage at the thread.Because of the damage, the dimensions which are relevant for this complained condition could not be checked.Concomitant slide hammer (part 03.010.056): there are scratches and marks everywhere on the device.The laser etching is difficult to read.The locking mechanism works properly.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Due to the complaint description there is no allegation against the slide hammer.The investigation of the hammer guide has shown that both devices are functional as intended.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

Updated concomitant device: slide hammer (part 03.010.056, lot 1313098, quantity 1).

Manufacturer Narrative

Catalog number.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.

• Brand Name: CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6526858
• MDR Text Key: 73861645
• Report Number: 3003875359-2017-10202
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2017

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: 03.010.000
• Device Lot Number: 3206217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2017; 06/16/2017; 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BLADE (PART AND LOT UNKNOWN, QTY 1); SLIDE HAMMER (03.010.056,LOT UNKNOWN, QTY 1); TIBIA NAIL (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention