MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.034S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient gender and weight not available for reporting.Date of implant is not known complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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.(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

It was reported that the patient underwent hardware removal on (b)(6) 2018 due to prominence of the implanted proximal femoral nail anti rotation (pfna) blade.The blade was removed, but pfna nail and distal locking screw were left in the patient.It is unknown if there was a surgical delay or what the patient outcome was.It is not known where or when the pfna construct was implanted.Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1), distal locking screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) pfna blade.This is report 1 of 1 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.Additional narrative: device evaluated by mfr, device manufacture date: device history record (dhr) review: part: 04.027.034s; lot: l560129; manufacturing site: bettlach; release to warehouse date: 07.Sep.2017; expiry date: 01.Aug.2027.The device history record shows this lot of 40 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual 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.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.Dhr review was completed.Part: 04.027.034s.Lot: l560129.Manufacturing site: bettlach.Release to warehouse date: 07.Sep.2017.Expiry date: 01.Aug.2027.The device history record shows this lot of 40 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual 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 customer quality conducted an investigation of the returned device.Investigation flow: functional: visual inspection: visual inspection performed at customer quality (cq) confirmed the condition of migration of device, per the images provided.The blade was observed backed out.The observed condition agrees with the reported complaint condition.Therefore, the complaint was confirmed and no new issues such as breakage were identified.Document/specification review: following drawings were reviewed during investigation.No product design issues or discrepancies were observed.Top-level drawing for blade: dimensional inspection: dimensional analysis was not able to be performed on the relevant features contributing to complaint condition as the device was not returned.The device history record shows this lot of 40 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional 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.Dcrm reviewed during investigation showed that occurrence rate of harm documented has been exceeded with this complaint.However, an immediate revision to the risk document is not required at this time because the documented risk level remains unchanged.Per the work instruction: risk management document updates, a revision to the risk document is not required when the occurrence rate in the dcrm/prm is exceeded if the risk level does not change.Per document, product risk management, the criteria for risk acceptability and escalation of residual risks to the risk management report for risk-benefit analysis is based on risk level, to which the probability of occurrence of harm and severity of harm are components.Fluctuations in the occurrence rate may happen monthly as sales and complaint data reporting from the field changes over time.The annual/periodic risk review as part of the post market safety surveillance plan assess if a risk managements document update is required considering trending of complaints or other post market events during the scheduled time period.Conclusion: no root cause could be determined based of the information provided.The complaint is confirmed; however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Therefore, 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: PFNA BLADE PERF L95 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf PA 4436 ; SZ 4436
• MDR Report Key: 7838337
• MDR Text Key: 118939933
• Report Number: 2939274-2018-53568
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819368989
• UDI-Public: (01)07611819368989
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.034S
• Device Lot Number: L560129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention