MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT Ø3.4 SELF-TAP L44 TAN VIOL; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 462.444

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient age, date of birth, and weight not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.Udi and 510k not available.Device malfunctioned intra-operatively and was not implanted/explanted.(b)(6).A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 europe reports an event in (b)(6) as follows: it was reported that during a procedure to implant a solid humeral nail on (b)(6) 2018, the 3.4mm locking bolt bent at the moment of compression.Surgery was completed successfully with no delay.Patient status reported as stable.Concomitant devices reported: solid humeral nail (part number unknown, lot number unknown, quantity 1), screwdriver (part number unknown, lot number unknown, quantity 1).This report is for one (1) 3.4mm solid humeral nail.This is report 1 of 1 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.Device history record (dhr) review: part number: 462.444; synthes lot number: 1476670; release to warehouse date: april 24, 2006; manufacturing site: mezzovico.No nonconformance records (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.Investigation summary: flow: damaged: visual (appearance not as expected).Visual inspection: the locking bolt (part 462.444, lot 1476670, mfg 24 april 2006) was received at us customer quality (cq) bent.Additionally, the drive recess is worn and the balance of the device has deformations consistent with removal.This is consistent with the reported complaint condition.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed.Document/specification review: the device drawing(s) was reviewed; dhr review showed no ncr¿s were generated during production.Conclusion: the complaint condition is confirmed as the device (part 462.444, lot 1476670) was received bent.There is no indication that a design or manufacturing issue contributed to the complaint.No definitive root cause could be determined.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: BOLT Ø3.4 SELF-TAP L44 TAN VIOL
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7546135
• MDR Text Key: 109314902
• Report Number: 8030965-2018-53987
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 462.444
• Device Lot Number: 1476670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1