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

Model Number	399.091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.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 or Problem Description
It was reported that on (b)(6) 2019, a bone holding forceps soft ratchet clamp was broken when attempted to use.There was no patient involvement.This report is for one (1) bone holding forceps-soft ratchet.This is report 1 of 1 for complaint (b)(4).
Additional 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: a device history record (dhr) review was conducted: part number: 399.091, synthes lot number: 4592592, supplier lot number: 5000673, release to warehouse date: 07-may-2003, supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A manufacturing record evaluation was performed for the finished device 4592592number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Service & repair history: no service history review can be performed as part number with lot number(s) is a lot/batch controlled item.The service history review is unconfirmed.Service & repair evaluation: the customer reported that the device was broken.The repair technician reported the leaf spring of the device was broke.The cause of the issue is unknown.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: leaf spring, screw.The item was repaired per the inspection sheet, passed synthes final inspection on 28-jan-2019 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8274937
• Report Number: 2939274-2019-56047
• Device Sequence Number: 1952777
• Product Code: HTD
• UDI-Device Identifier: 10886982202314
• UDI-Public: (01)10886982202314
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: 399.091
• Device Catalogue Number: 399.091
• Device Lot Number: 4592592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1