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

Model Number	02.110.150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history lot: part number: 02.110.150.Lot number: h621796.Part manufacturing date: april 27, 2018.Manufacturing site: elmira.Part expiration date: n/a.Non-conformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h621796 of lcp wrist fusion standard bend plates was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h503025 met all specifications with no issues documented that would contribute to this complaint condition.Device history review: a review of the device history record revealed no complaint related anomalies.This 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 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) 2020, a hardware removal was performed due to a nonunion.The original case was done (2) two years ago and the patient did not follow up.However, the patient began lifted cement bags and the plate loosed and the fixation failed.Thus, a wrist fusion plate was removed from the patient and bone grafted was done and a new wrist fusion plate was used to fixate.The procedure outcome was unknown.There was no patient consequence.This is report 01 of 07 of (b)(4).

• Brand Name: 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: 9695688
• Report Number: 2939274-2020-00779
• Device Sequence Number: 2844662
• Product Code: HRS
• UDI-Device Identifier: 10886982030399
• UDI-Public: (01)10886982030399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.110.150
• Device Catalogue Number: 02.110.150
• Device Lot Number: H621796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 88