MAUDE Adverse Event Report: SYNTHES GMBH FORCEPS FOR USE WITH CERCLAGE BUTTONS AND POSITIONING PINS

Catalog Number	391.885
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 391.885.Lot number: a7ja07.Manufacturing site: tuttlingen.Release to warehouse date: week 07, 2000.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 21 years old).Visual inspection: the hold-forceps f/cercl eyes + position-pin (p/n: 391.885, lot #: a7ja07) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that retaining pieces on the tip were broken off from the device and not returned.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.A functional test was performed and the forceps was functioning as intended but the broken retaining pieces potentially caused the complaint condition.Can the complaint be replicated from the returned device? yes.No dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed, forceps.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the hold-forceps f/cercl eyes + position-pin (p/n: 391.885, lot #: a7ja07).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces on the device.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 (b)(6) reports an event as follows: it was reported that on an unknown date a holding forcep wouldn't hold the cable crimp.It is unknown if there was a surgical delay.The procedure outcome and patient status are unknown.This report is for one (1) forceps for use with cerclage buttons and positioning pins.This is report 1 of 1 (b)(4).

• Brand Name: FORCEPS FOR USE WITH CERCLAGE BUTTONS AND POSITIONING PINS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11556642
• Report Number: 8030965-2021-02228
• Device Sequence Number: 3844404
• Product Code: HTD
• UDI-Device Identifier: 07611819719866
• UDI-Public: 07611819719866
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/12/2021

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: 391.885
• Device Lot Number: A7JA07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1