MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II BLADE L95 TAN; APPLIANCE,FIXATION,NAIL, PLATE COMBO, SINGLE COMPONENT

Catalog Number 04.027.054S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.Udi:(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Concomitant devices: therapy dates: (b)(6) 2017 1x 473.035s / lot unk (pfna-ii ø9 long r 125° l300 tan), 2x 459.420vs / lot unk (bolt ø4.9 self-tap l42 tav green), 1x 473.170s / lot unk (pfna-ii end cap extens.0 tan); 510k# unknown.Device history records review was conducted.The report indicates that the: part #04.027.054s / lot #l061514 manufacturing location: (b)(4) manufacturing date: 18.Jul.2016 expiry date: 01.Jul.2026.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.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.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 reported devices were used in the surgery for the femoral subtrochanteric fracture on (b)(6) 2017.The pfna (proximal femural nail antirotation) long was used for the procedure.As instructed in the user¿s manual, the surgeon connected the inserter to the compression blade by turning the inserter counter-clockwise.The surgeon made sure that the blade was unlocked and then inserted the blade into the inserter.After the surgeon inserted the blade at the proper position, the surgeon tried to turn the inserter clockwise; however, the blade could not be locked since the blade did not move at all.The blade was removed and not used in the patient.The operation was completed by using another size of the blade.When the inserter was connected to the blade, the surgeon did not tighten the devices too much or connect these devices in the wrong way.The surgery was extended for 5 minutes.No adverse consequence to the patient was reported.This complaint involves 1 part.Concomitant devices: 1x 473.035s / lot unk (pfna-ii ø9 long r 125° l300 tan), 2x 459.420vs / lot unk (bolt ø4.9 self-tap l42 tav green), 1x 473.170s / lot unk (pfna-ii end cap extens.0 tan).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing evaluation was completed.The product was returned in a packaging different from the original synthes bag.The laser marking was readable.Traces of use were visible on the blade and its helix.The blade could be disassembled without problems.No manufacturing error was found.The raw material certificates were checked and the used raw material has fulfilled the specifications.Based on the investigation results, this complaint is not confirmed because the blade could be disassembled without problems.In addition, the manufacturing documentation shows that the product was manufactured according his specifications.Definitive root cause could not be determined.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.

• Brand Name: PFNA-II BLADE L95 TAN
• Type of Device: APPLIANCE,FIXATION,NAIL, PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• 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: 6836168
• MDR Text Key: 84690652
• Report Number: 9612488-2017-10449
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H10
• 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
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: L061514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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