MAUDE Adverse Event Report: SYNTHES GMBH REDUC-FORC W/POINT SOFTLO L155; FORCEPS

Catalog Number 399.086

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: 399.086; lot number: 5931752; manufacturing site: (b)(4); release to warehouse date: jan 20, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 were found to have a broken tip.There was no patient involvement.There was no further information provided.This report is for one (1) reduc-forc w/point softlo l155.This is report 1 of 1 for (b)(4).

• Brand Name: REDUC-FORC W/POINT SOFTLO L155
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; 1020 WIEN; AU 1020 WIEN
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10870014
• MDR Text Key: 219377388
• Report Number: 8030965-2020-09079
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819220935
• UDI-Public: (01)07611819220935
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/26/2020

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: 399.086
• Device Lot Number: 5931752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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