MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP, BONE

Catalog Number 311.01.96

Device Problem Crack (1135)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in the usa as follows: it was reported that on (b)(6),2022 the handle cracked on an unknown reason.No patient consequences was reported due to this event.This complaint involves one (1) device handle with mini quick coupling.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.The initial reporter is a j&j sales representative.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.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.The customer reported the handle cracked on an unknown reason.The repair technician reported handle broken.The sleeve and knurled cap are also missing.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is damaged component.The item will be forwarded to customer quality.The evaluation was confirmed.

• Brand Name: HANDLE WITH MINI QUICK COUPLING
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14857340
• MDR Text Key: 303241653
• Report Number: 2939274-2022-02417
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982187208
• UDI-Public: (01)10886982187208
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.01.96
• Device Lot Number: A4JG499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/1999
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1