MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PERCUTANEOUS INSERTION HANDLE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.046
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Device is an instrument and is not implanted/explanted.(b)(4).The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient was implanted with a retrograde/antegrade femoral nail (rafn) to treat the distal femur fracture on (b)(6) 2018.During the procedure the two (2) distal screws missed the nail hole (rafn) which caused the screws inserted posteriorly.The connecting screw was tightly secured to the insertion handle and pre-checking of the nail and jig alignment was done and it was aligned perfectly.Surgeon doesn¿t know why the jig would have missed the nail, given that the connecting screw was tight too.The surgeon had to remove the 2 screws and replace it with a spiral blade for the nail.There was a three (3) minute surgical delay to the procedure.No patient consequences reported.This report is for one (1) percutaneous insertion handle.This is report 1 of 3 for complaint (b)(4).
Additional 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: dhr review was completed.Part no.: 03.010.046, lot no.: l337806, and manufacturing location: (b)(4).Release to warehouse date: 12.May.2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The returned insert-handle long f/expert fn was forwarded to the manufacturing site and was checked for conformance to the specifications.Received 1 article of insert-handle long f-expert fn for manufacturing investigation.The insert-handle long f-expert fn is in a used condition, minor traces of use on the surface are present.The review of the device history record revealed that this instrument was manufactured in may 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity reported.During manufacturing investigation, all relevant and significant characteristics like dimensions were checked and additionally, the article passed all functional tests.All checked characteristics are within the specifications.There are no references to the reported issue, no misalignment or production error of 03.010.046 insert-handle long f-expert fn has been found.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: date returned to manufacturer: 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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7399650
• Report Number: 8030965-2018-52794
• Device Sequence Number: 1470341
• Product Code: LXH
• UDI-Device Identifier: 07611819773554
• UDI-Public: (01)07611819773554(10)L337806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.046
• Device Lot Number: L337806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR