MAUDE Adverse Event Report: SYNTHES GMBH REDUC-FORCEPS TOOTHED RATCH-LOCK L140

Catalog Number 399.99

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned and therefore, no further investigation is possible.Reviewing attached picture, the reported complaint condition of "breakage" can be confirmed.We found that one forceps tip is broken.The broken fragment is not visible on the picture.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part number: (b)(4).Lot number: t159220 manufacturing site: tuttlingen release to warehouse date: (b)(6) 2017.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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 (b)(6) as follows: it was reported that on an unknown date, the forceps was broken.It was unknown how and when it was occurred.There was no surgery and patient involvement.This complaint involves one (1) device.This report involves one (1) unk - drill bits: trauma.This is report 1 of 1 for (b)(4).

• Brand Name: REDUC-FORCEPS TOOTHED RATCH-LOCK L140
• 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 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11219643
• MDR Text Key: 228553245
• Report Number: 8030965-2021-00584
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819028135
• UDI-Public: (01)07611819028135
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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: 399.99
• Device Lot Number: T159220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1