MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 6 HOLE/163MM/LT; PLATE, FIXATION, BONE

Model Number	02.123.025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Patient weight is unknown complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient with a bone marrow aspirate concentrate bone graft implant was treated for nonunion of the humerus with a locking compression plate (lcp) and unknown screws on an unknown date.The patient then began experiencing pain and eventually, the screw heads broke off in the distal portion of the lcp.The patient was then revised on an unknown date to a proximal humerus plate after the humerus was shortened a little to ensure good bone contact and 10cc of vivigen was implanted.It was unknown if there was a surgical delay.Patient and procedure outcomes were unknown.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
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
Reportedly the procedure was completed successfully and the patient status was stable.
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.
Event or Problem Description
It was further reported that there was no surgical delay.

• Brand Name: 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 6 HOLE/163MM/LT
• 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: 7637277
• Report Number: 2939274-2018-52624
• Device Sequence Number: 1946137
• Product Code: HRS
• UDI-Device Identifier: 10886982042132
• UDI-Public: (01)10886982042132
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2018

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: 02.123.025
• Device Catalogue Number: 02.123.025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 08/22/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/02/2018; 08/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR