MAUDE Adverse Event Report: SYNTHES GMBH REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Catalog Number 399.99

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2024

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.H10 additional narrative: e1: initial reporter is j&j company representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 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 canada as follows: it was reported an alligator clamp broke intraoperatively on (b)(6) 2024.Surgery was not delayed.Procedure was successfully completed by using the other clamp in the set.Fragments were generated but were removed from patient field.Patient status is unknown.This report is for one reduction forceps with serrated jaw-ratchet 144mm for (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.H3, h4, h6 investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that one jaw of the device is broken off.A dimensional inspection was not performed since it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the red forceps serrated jaw-ratchet 144 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Dimensional inspection: n/a.Device history part number: 399.99 lot number: a7pa15 (wo# (b)(4)).Manufacturing site: tuttlingen release to warehouse date: 20-apr-2006 (wo# (b)(4)), 18-apr-2006 (wo# (b)(4)), 12-apr-2006 (wo# (b)(4)), 20-apr-2006 (wo# (b)(4)).A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device (over 17 years old).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 the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the one of the end of jaw of red forceps serrated jaw-ratchet 144 was broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the red forceps serrated jaw-ratchet 144 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to component failaure 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 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.The device lot number is unknown, therefore a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.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: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): TUTTLINGEN; unter hasslen 5; tuttlingen CO 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18640968
• MDR Text Key: 334644871
• Report Number: 8030965-2024-01944
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 399.99
• Device Lot Number: A7PA15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 03/19/2024
• Supplement Dates FDA Received: 02/19/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2006
• 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