MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH END-CAP F/A2FN CANN EXTENS. 5 TAN GREY; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.009.001S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) medical center.Device is not distributed in the united states, but is similar to device marketed in the usa.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a patient underwent removal of afn implants due to the bone union being completed.During the removal surgery, the surgeon could not untighten the end cap because it was stuck in the nail.The surgeon removed all the screws laterally implanted and hooked the hole of lateral side by bending a k-wire.After removing the nail and end cap together, the end cap could not be detached from the nail.The removal surgery was successfully completed.There was a surgical delay of less than thirty (30) minutes.The patient was reported as stable after the procedure.The initial surgery, for the femoral diaphyseal fractures with the afn implants, was performed on (b)(6) 2019.The surgeon commented that at the time of primary surgery the end cap may have been strongly inserted, and possible in-growth tissue may have occurred between the end cap and the nail.Concomitant devices reported: locking screws (part number unknown, lot unknown, quantity unknown), expert a2fn nail ø10 r cann l320 tan lig (part number 04.009.344s, lot 1l62563, quantity 1).This report involves one (1) end-cap f/a2fn cann extens.5 tan grey.This is report 1 of 2 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.H3, h6: part: 04.009.001s, lot: 3l94157, manufacturing site: mezzovico, release to warehouse date: 12.April 2019, expiry date: 01.April 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: upon visual inspection of the complaint device it can be seen that the two (2) returned implants stuck together, this thus confirming the complaint description.The nail has scratches and dents at proximal end and the end-cap has scratches and dents all over, these damage resulted most likely from holding with pliers by explantation.Furthermore, the end-cap recess is deformed condition, most likely from trying to disassemble the parts.Functional test: a functional test is not possible, as we are not able to disassemble the parts.Dimensional inspection: the complaint relevant dimensions cannot be checked for dimensional accuracy, as we are not able to disassemble the parts.Document/specification review: drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Summary: we are also not able to disassemble the returned two (2) parts, based on this complaint and complaint is confirmed.Device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in april 2019.No ncrs were marked in the dhr during production.Moreover, a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.The parts were implanted with no allegation and stayed in situ for nearly 11 months with no allegation.Unfortunately, we are not able to determine the exact reason for this reported problem, but we assume that the cause of this problem could be a cold welding of the end-cap inside of the nail thread or it could be that soft tissue could have growth between end-cap and nail.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.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: END-CAP F/A2FN CANN EXTENS. 5 TAN GREY
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10546174
• MDR Text Key: 207310409
• Report Number: 8030965-2020-07129
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.009.001S
• Device Lot Number: 3L94157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 10/08/2020
• Patient Sequence Number: 1
• Treatment: EXPERT A2FN NAIL Ø10 R CANN L320 TAN LIG; UNK - SCREWS: LOCKING; EXPERT A2FN NAIL Ø10 R CANN L320 TAN LIG; UNK - SCREWS: LOCKING
• Patient Age: 17 YR