MAUDE Adverse Event Report: SYNTHES GMBH RED FORCEPS POINTS NARROW-RATCHET 132

Catalog Number 398.40

Device Problem Device Slipped (1584)

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

Event Date 01/01/2023

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.E3: reporter is a j&j employee.H3, h4, h6: part number: 398.40.Lot number: t178104.Manufacturing site: tuttlingen.Release to warehouse date: 25-jan-2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that red forceps points narrow-ratchet 132 were fully opened, however functionality of the device cannot be assessed through photo investigation.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 it had broken from the tip.The broken fragment was not returned for evaluation.The reported allegation of loose cannot be confirmed.No other defect was found.The photo analysis and photo evidence doesn't match with the physical device.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was not confirmed as the observed condition of the red forceps points narrow-ratchet 132 not contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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

It was reported that on an unknown date, the ratchet will not hold.Surgical delay is unknown.No patient consequence.Upon manufacturers investigation the instrument was identified as broke, this report involves one (1) reduction forceps with points narrow-ratchet 132mm.This is report 1 of 1 for (b)(4).

• Brand Name: RED FORCEPS POINTS NARROW-RATCHET 132
• 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: 19097074
• MDR Text Key: 340032806
• Report Number: 8030965-2024-05024
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201355
• UDI-Public: 10886982201355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 398.40
• Device Lot Number: T178104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2019
• 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