MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT Ø4.9 SELF-TAP L34 TAV GREEN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 459.340VS

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Occupation: synthes employee.Device is not distributed in the united states but is similar to device marketed in the usa.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 in (b)(6) 2018, the patient underwent an implant surgery for femoral sub-trochanteric fracture with the pfna and the nail was break on (b)(6) 2019.The hospital followed up the patient without any removal surgery, but the fracture part didn¿t unite.In (b)(6) 2019, the nail broke at the fracture part due to non-union.The day after that, the patient underwent re-operation, and the re-operation was completed successfully.The fracture was atypical fracture, and it caused non-union and the breakage of the nail.This is report 3 of 3 for (b)(4).Related product complaints: (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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot part: 459.340vs, lot: 5939410, manufacturing site: salzburg, release to warehouse date: july 05, 2016, expiry date: june 01, 2026.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: BOLT Ø4.9 SELF-TAP L34 TAV GREEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9511715
• MDR Text Key: 186602928
• Report Number: 8030965-2019-71375
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819702523
• UDI-Public: (01)07611819702523
• 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: 12/03/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 459.340VS
• Device Lot Number: 5939410
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention