MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.314S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier, gender and weight are not available for reporting.Additional device product code: hwc.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4) used to capture change in surgical plan: the surgeon used another nail from another lot to complete the procedure with a reported delay of 20 minutes.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 the it was impossible to lock the nail with the locking screw during a surgery performed on (b)(6) 2018.It was impossible to insert the superior locking screw.There was twenty (20) minutes of surgical delay due to the reported issue.Another nail was used to complete the procedure.The surgery was completed successfully without any harm to the patient.Concomitant devices reported: bolt ø4.9 self-tap l34 tan green (part # 459.340s, lot # unknown, quantity 1), guidewire ø3.2 f/pfna blade (part # 356.830s, lot # unknown, quantity 1).This report is for one (1) 10mm/125 deg ti cann troch fixation nail 170mm-sterile.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

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.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

Further it was reported that the distally hole screw was not being locked and not the superior hole screw as previously reported.There is no problem with the screw but with the hole of the tfn.

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.Additional narrative: device evaluated by mfr, device manufacture date: sterile part: 456.314s, lot: l696887: release to warehouse date: december 14, 2017.Expiry date: december 01, 2027.Supplier: früh.Manufacturing site: selzach.Non-sterile part: 456.314, lot: h461238: manufacturing location: monument.Manufacturing date: september 26, 2017: component parts and raw material certificates were reviewed and met specification.Inspection sheet for in-process/inspect dimensional/final inspection met inspection acceptance criteria.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 this product that would contribute to this complaint condition.Device evaluated by mfr: a product investigation was completed: the returned nail shows slightly traces of damage in the proximal hole.Due this, the anodized color was found partially disappeared.The device passed the required functional check at customer quality department successfully.The functionality test was performed with corresponding demo equipment.Our investigation has shown that the complaint condition could not be confirmed.Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened.It is likely that a connection issue with the nail, e.G.Not mounted aligned, could have caused the malfunction of all devices.Based on this result and without all involved parts, we conclude that the cause of failure is not due to any manufacturing non-conformances.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.

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.Updated 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

Updated concomitant devices: bolt ø4.9 self-tap l34 tan green (part 459.340s, lot l646612, quantity 1), guidewire ø3.2 f/pfna blade (part 356.830s, lot l748648, quantity 1).

• Brand Name: 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7447735
• MDR Text Key: 106088245
• Report Number: 8030965-2018-53266
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819764170
• UDI-Public: (01)07611819764170
• Combination Product (y/n): N
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.314S
• Device Lot Number: H461238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR