MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.000S

Device Problems Misassembled (1398); Use of Device Problem (1670); Component Misassembled (4004)

Patient Problem No Code Available (3191)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).It was reported that the insertion angle of the guide wire was not proper.The end cap could not be inserted and assembled to the nail.The incision was extended to attempt to assemble the end cap to the nail.The surgery was completed without the end cap with a reported delay of 30 minutes.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during open reduction internal fixation with trochanteric fixation nail advance (tfna) system that was applied to femoral trochanteric fractures, the tfna end cap in question could not be inserted on the unknown tfna nail.The surgeon removed the unknown insertion handle from the unknown tfna nail and tried to insert the tfna end cap in question over an unknown guide wire with hook using a stardrive screwdriver.However, the insertion angle was not proper, thus, the tfna end cap could not be inserted.The surgeon removed the tfna end cap and rotated the unknown tfna nail to inner direction, and re-tried to insert the tfna end cap.However, it could not be fully inserted in the unknown tfna nail.The surgeon checked the locking mechanism and confirmed that it was engaged properly.The incision was extended and the unknown tfna nail was rotated further.The surgeon re-tried to insert the tfna end cap using an unknown flexible driver but failed.The surgeon gave up inserting the tfna end cap and left the unknown tfna nail in the patient with no tfna end cap.The surgery was completed with a 30-minute delay due to the reported event.There was no adverse consequence to the patient.Concomitant devices reported: unknown insertion handle (part #: unknown, lot #: unknown, quantity: 1), unknown stardrive screwdriver (part #: unknown, lot #: unknown, quantity: 1), unknown flexible driver (part #: unknown, lot #: unknown, quantity: 1).This complaint involves three (3) devices.This report is for one (1) ti end cap for tfna 0mm extn - sterile.This report is 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10: part received device history records, part: 04.038.000s, lot: 1l61692, manufacturing site: bettlach, release to warehouse date: 26.Oct.2018, expiry date: 01.Oct.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary summary of the manufacturing evaluation: based on the investigation results this complaint is rated as confirmed since the end cap has failed its functional test through a go gage.However, from the manufacturing point of view this complaint is rated as no valid due to the article has been received strongly damaged (see visual inspection section) for this investigation.For more details, please see attached documentation of manufacturing evaluation.Because of these damages the color has been removed, which from the manufacturing point of view not this has been caused out of the manufacturing process.This clearly indicates post-manufacturing damages.There were inspections documented in the dhr (16299467) -including 100% inspection of the color-.Thus, a manufacturing issue has been excluded; therefore, no additional actions have been required.No product fault could be identified.Misalignment during insertion could be identified as most probable root cause of the reported problem.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed 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 0MM EXTN - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8317952
• MDR Text Key: 135516225
• Report Number: 8030965-2019-60764
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 1L61692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention