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

Catalog Number 391.885

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; SZ 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11556642
• MDR Text Key: 244681220
• Report Number: 8030965-2021-02228
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819719866
• UDI-Public: 07611819719866
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1