MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 5MM EXTN ¿ STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.005S

Device Problem Failure to Align (2522)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the osteosynthesis with tfna devices was applied to femoral trochanteric fractures.During the procedure, the end cap 0mm (04.038.000s) did not succeed.The surgeon used end cap 5mm (04.038.005s), which failed as well.Without trying any other end caps, the surgeon finished the surgery with 30 minutes delay.There was no adverse consequence to the patient.Patient outcome was reported as stable.Concomitant device reported: tfna nail (part# 04.037.113s, lot# 9849632, quantity 1).This report is for one (1) ti end cap for tfna 5mm extn ¿ sterile.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6: a device history record (dhr) review was conducted for part: 04.038.005s, lot: l357843: manufacturing site: bettlach, release to warehouse date: 06.Apr.2017, expiry date: 01.Apr.2024: the device history record shows this lot of 50 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and material criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was conducted.As relevant for the complaint condition ¿the endcap in question could not be assembled¿, a functional test through a go/no go gage has been performed to test the functional feature.The thread m11x1 ¿ 6g was tested and has fulfilled the specifications through the go/ no go gages.Besides, during the manufacturing process this feature was inspected through the relevant inspection sheet and the whole lot has passed its specifications.Therefore, any manufacturing issue has been excluded.Based on the investigation results this complaint is rated as not confirmed since from the manufacturing point of view the relevant feature was tested and has fulfilled its specification (see attachments) as well as in the manufacturing documentation no issue was identified.The device is functional as required, it can only be assumed that the thread of the nail was damaged after the unsuccessful insertion of the first end cap.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: TI END CAP FOR TFNA 5MM EXTN ¿ STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7651837
• MDR Text Key: 112850788
• Report Number: 8030965-2018-54733
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652118
• UDI-Public: (01)07611819652118
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 04.038.005S
• Device Lot Number: L357843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 08/06/2018
• Patient Sequence Number: 1