MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES; PLATE, FIXATION, BONE

Model Number	02.111.900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative nonunion is unknown.Additional device product code: hwc.Date of explant reported as september 2018; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted.Part: 02.111.900 , lot: 9754930 , manufacturing site: (b)(4), release to warehouse date: 15.Dec.2015 the device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a removal of one (1) locking compression plate (lcp) ulna osteotomy plate 6 holes and six (6) unknown 2.7mm diameter screws on (b)(6) 2018 due to nonunion.The patient underwent an ulna shortening osteotomy and was implanted with the original hardware on (b)(6) 2016.Patient was revised with a synthes 3.5mm locking compression plate (lcp) with bone graft.It was unknown if there was any surgical delay.Surgical procedure was successful and patient outcome was stable.This report is for one (1) 2.7mm lcp ulna osteotomy plate 6 holes.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES
• 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: 7956975
• Report Number: 2939274-2018-54316
• Device Sequence Number: 13685681
• Product Code: HRS
• UDI-Device Identifier: 10886982032454
• UDI-Public: (01)10886982032454
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 02.111.900
• Device Catalogue Number: 02.111.900
• Device Lot Number: 9754930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention