MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 473.170S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the patient underwent an unknown surgery for proximal femoral nail antirotation (pfna).The surgery was completed successfully without any surgical delay.On (b)(6) 2022, it was confirmed that cut-out occurred.The revision surgery was done on (b)(6) 2022.The pfna was removed and replaced with an artificial head.The surgeon commented that femoral neck fracture was the cause of the cut-out.It is unknown when the femoral neck fracture occurred.This is report 3 of 4 for complaint (b)(4).This report is for pfna end cap.

Manufacturer Narrative

Additional narrative: event date: event is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.No code is for revision surgery and injury the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part #: 473.170s, lot #: l568150, manufacturing site: werk bettlach, supplier: n/a, release to warehouse date: 25 sep 2017, expiration date: n/a.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the pfna-ii end cap extens.0 tan.The provided radiographic image was reviewed and no defects or damages were observed with the end cap.A dimensional inspection was not performed for the pfna-ii end cap extens.0 tan due to the complex geometry of the device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the pfna-ii end cap extens.0 tan was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 END CAP EXTENS. 0 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14356626
• MDR Text Key: 291384672
• Report Number: 8030965-2022-03124
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819837652
• UDI-Public: (01)07611819837652
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 473.170S
• Device Lot Number: L568150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAILS: PFNA
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female