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

Catalog Number 473.122VS

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the revision surgery using trochanteric fixation nail-advanced (tfna) nail and agmt after removing proximal femoral nail (pfn).Pfn removal was difficult due to callus and thickened cortex; however the nail was finally removed.But at that time, it was found that the pfn had broken at the location where locking screw inserted in the distal part of the pfn.Because there was no backup of a plate, the surgeon tried to hit the nail which remained in the bone into the distal side, but the remained nail did not move slightly.When the surgeon tried to move the remained nail by shaving the medullary cavity around the nail with a k-wire, it resulted in a complete fracture, so the surgeon directly developed the fracture part and removed the remained nail.After that, the fracture was fixed with the planned procedures using tfna long and agmt.The revision surgery was completed with over thirty (30) minutes delay.No further information is available.This report captures the intra-op event of pfn nail breakage which occurred during the revision surgery; while related complaint (b)(4) reports the postoperative event of revision surgery due to pain development.This report is for one (1) pfn ø11 short 130° l200 tav green.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.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: h3, h6: a photo investigation was completed: an investigation was completed based on the provided x-rays.Visual analysis of the x-rays revealed the device is broken.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 confirmed.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.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: 12965168
• MDR Text Key: 287811093
• Report Number: 8030965-2021-10072
• 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
• Report Date: 11/11/2021

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?: No
• Is this a Product Problem Report?: Yes
• 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: 12/21/2021
• 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 - NAIL HEAD ELEMENTS: PFN BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Sex: Female