MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

Catalog Number	398.41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Snythes rep: device history records: part number: 398.41, synthes lot number: t933354, release to warehouse date: 25-feb-2009, manufacture site: (b)(4), part expiration date: n/a, list of non-conformance: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's subcomponents that would contribute to the complaint condition.Traceability to the raw material lot number could not be established during this dhr review.No ncrs were generated during the production of this device.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.
Event or Problem Description
It was reported that on (b)(6) 2019 during open reduction internal fixation (orif) humerus, the reduction forceps with points broad-ratchet and tip broke off in bone and was retrieved.Nothing left in patient.There were fragments generated from broken device.Fragments were removed easily with no delay.There was no other medical intervention required.Procedure was successfully completed with no surgical delay.Patient status is unknown.This complaint involves one (1) device.This report is 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 corrected data: b4, g4: these dates were inadvertently reported as 1/25/2019 in the initial report.The correct date is 1/24/2019.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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: h10, omit verbiage: device report from synthes reports an event in japan as follows from initial medwatch.Device was used for treatment, not diagnosis.

• Brand Name: REDUCTION FORCEPS WITH POINTS BROAD-RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8343679
• Report Number: 2939274-2019-56471
• Device Sequence Number: 1867010
• Product Code: HTD
• UDI-Device Identifier: 10886982201386
• UDI-Public: (01)10886982201386
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2019

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 Catalogue Number: 398.41
• Device Lot Number: T933354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019; 03/25/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 02/15/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1