MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

Catalog Number 399.091

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that following wash on an unknown date, several products were found to be faulty.Upon manufacturer investigation, the device was discovered to be broken.There was no patient involvement.This report is for a bone holding forceps.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Initial reporter is a synthes employee.Part: 399.091.Synthes lot: 4065981.Supplier lot: 5007.Release to warehouse date: february 02, 2000.Supplier: (b)(4).No nonconformance (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the received images.The images were reviewed, and the complaint condition is confirmed.The spring of the bone holding forceps is broken into two pieces at the spring screw hole.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection was not completed.A document/specification review was completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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.

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: h6 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: BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12970234
• MDR Text Key: 283599644
• Report Number: 2939274-2021-07016
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 07611819220959
• UDI-Public: (01)07611819220959
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: 399.091
• Device Lot Number: 4065981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CANNULATED SD SCREWDRIVER SHAFT/T15; CONNECTOR FOR THREADED EXTRACTION HOOKS; DRILL GUIDE F/CANNUL-ANGLED BLADE PL 3.5; HOLD-SL F/314.020 314.030 314.070 314.55; RED FORCEPS SERRATED JAW-RATCHET 144; SMALL HEXAGONAL SCRDRIVER HOLDING SLV; UNIV-CHUCK W/T-HANDLE; UNIV-CHUCK W/T-HANDLE