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

Catalog Number	359.217
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).
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.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
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10072551
• Report Number: 8030965-2020-03596
• Device Sequence Number: 665840
• Product Code: HTZ
• UDI-Device Identifier: 07611819096646
• UDI-Public: (01)07611819096646
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUTTER F/TEN; CUTTER F/TEN