MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP WRIST FUSION STANDARD BEND PLATE; PLATE, FIXATION, BONE

Model Number	04.110.150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Additional contact person: or head nurse, (b)(6).(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.The implant was reported to have failed post-operatively.There is no report of device malfunction.A review of the device history record.Device history lot.Part number: 04.110.150.Lot number: h582221.Part manufacture date: 06-mar-201.8 manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti lcp wrist fusion standard bend plate product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that 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.
Event or Problem Description
It was reported that on an unknown date, the valley health medical center from pathology department got a reposition with information from the doctor involved in a case.A titanium wrist fusion standard bend plate was removed and must go to the company for analysis.It is unknown if there was surgical delay.Procedure outcome and patient status were unknown.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity # 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.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: TI LCP WRIST FUSION STANDARD BEND PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8866245
• Report Number: 2939274-2019-59545
• Device Sequence Number: 11451721
• Product Code: HRS
• UDI-Device Identifier: 10886982100320
• UDI-Public: (01)10886982100320
• Combination Product (Y/N): N
• PMA/510(K) Number: K042355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.110.150
• Device Catalogue Number: 04.110.150
• Device Lot Number: H582221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention