MAUDE Adverse Event Report: SYNTHES GMBH PFN Ø11 SHORT 130° L200 TAV GREEN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 473.122VS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2012, the patient underwent surgery with proximal femoral nail (pfn).After the surgery, from the last year, pain developed near the distal locking screw.Signs of atypical femoral fractures (aff) were observed in the lateral part of the distal locking screw.Therefore, the revision surgery using trochanteric fixation nail-advanced (tfna) nail and agmt after removing pfn was planned.No further information is available.This report captures the postoperative event of revision surgery due to pain development while related complaint (b) (4) captures the event which occurred during the revision surgery.This report is for one (1) pfn ø11 short 130° l200 tav green.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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: h6: the photo was returned to us cq for evaluation.The us cq team conducted a visual inspection of the device from attachment.Visual analysis of the photo/x-ray revealed that no defects were found with the pfpfn ø11 short 130° l200 tav green.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for pfn ø11 short 130° l200 tav green.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H6: a device history record (dhr) review was conducted: part # 473.122vs.Lot # 2431441.Manufacturing site: selzach.Release to warehouse date: 18 dec2008.Expiration date: 01 dec2018.Supplier: synthes bettlach gmbh.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

• Brand Name: PFN Ø11 SHORT 130° L200 TAV GREEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12965083
• MDR Text Key: 281982843
• Report Number: 8030965-2021-10069
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819227545
• UDI-Public: (01)07611819227545
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 473.122VS
• Device Lot Number: 2431441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: PFN; UNK - END CAPS: PFNA; UNK - NAIL HEAD ELEMENTS: PFN BLADE; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Female