MAUDE Adverse Event Report: SYNTHES GMBH HAMMER GUIDE FOR TI ELASTIC NAILS; HAMMER, SURGICAL

Catalog Number	359.218
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 359.218, lot 40p5776: manufacturing site: (b)(4).Release to warehouse date: february 10, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection, it was observed that the distal threads were broken.There were scratches and discoloration observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.Dimensional inspection showed the relevant dimensions were conforming.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 (b)(6) reports an event as follows: it was reported an instrument were damaged following a case.There was no delay to the surgery and no patient impacted reported.Upon visual inspection, it was observed that the distal threads were broken.This report is for a hammer guide.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMER GUIDE FOR TI ELASTIC NAILS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12216431
• Report Number: 8030965-2021-06015
• Device Sequence Number: 4157765
• Product Code: FZY
• UDI-Device Identifier: 07611819104365
• UDI-Public: (01)07611819104365
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: 359.218
• Device Lot Number: 40P5776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: INSERTER F/TEN