MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CUTTER FOR TI ELASTIC NAILS; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 359.217

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The device was 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 norway as follows: it was reported on an unknown date during the cleaning/sterilization a chip was found off.The surgery outcome was unknown.There were no patient consequences.This complaint involves (1) device.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.H3, h6: only the following subcomponents were sent back for investigation, hence, the correct lot number of the top level part 359.217 could not be identified.Schluesselkoerper kpl.(article 50136517; product code 359.217.004) , doublehex sw11 (article 50101971; product code 321.200.002).Visual inspection visual inspection confimed that the component part 321.200.002 is damaged, there are two chips broken off.Dimensional inspection could not be performed due to the damage incurred.Document/specification review the following drawings were reviewed during the investigation (current version): cutter for ti elastic nails (359.217) handle for cutter 359.217 ten (359.217.004) doublehex sw11 (321.200.002) disassembly/assembly instruction, part 359.217.004 can be disassembled for reprocessing reasons.Spare parts: part# 321.200.002 and 359.217.004 are not available as spare parts.Summary: the complaint condition is confirmed as the component part 321.200.002 is damaged; there are two chips broken off.This doublehex sw11 is etched with lot# 1010 indicating that this part is more than 15 years old.The review of the production history could not be performed due to missing information, only the two component parts were returned for investigation, hence, the correct lot number of the top level part 359.217 could not be identified.However, considering the age of the damaged component part a wear or use related root cause is the most likely reason of the complained malfunction.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: CUTTER FOR TI ELASTIC NAILS
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10072551
• MDR Text Key: 191481198
• Report Number: 8030965-2020-03596
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 07611819096646
• UDI-Public: (01)07611819096646
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/06/2020

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: 359.217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUTTER F/TEN; CUTTER F/TEN