MAUDE Adverse Event Report: SYNTHES GMBH REDUCT-FORCEPS-LRG W/POINT SOFTLO L222

Catalog Number 399.092

Device Problem Break (1069)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in portugal as follows: it was reported that the orthokit arrived at the local warehouse with a device broke.This report is for one (1) reduct-forceps-lrg w/point softlo l222 this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Initial reporter occupation is a j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part number: 399.092 lot number: t190297 manufacturing site: tuttlingen release to warehouse date: 04-apr-2020.A review of the device history records was performed for the finished device lot number and a and a nc was started due to a rough surface of the connection area between the two handles which led to less room for the instrument to move freely.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that reduct-forceps-lrg w/point softlo l222 has one of the jaws is broken.No other issues was found.A dimensional inspection was not performed for the aiming reduct-forceps-lrg w/point softlo l222 due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the reduct-forceps-lrg w/point softlo l222 would contribute to the complained device issue.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.Drawing/specifications reviewed? yes, reviewed.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.

• Brand Name: REDUCT-FORCEPS-LRG W/POINT SOFTLO L222
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15990604
• MDR Text Key: 308115925
• Report Number: 8030965-2022-11188
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819220966
• UDI-Public: (01)07611819220966
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 399.092
• Device Lot Number: T190297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2020
• 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