MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM; PLATE, FIXATION, BONE

Model Number	02.107.304
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 date of birth and weight not available for reporting.Date patient pain and malunion began is not known.Additional product code: hwc.(b)(4) lot unknown.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone not available for reporting.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 a patient underwent a hardware removal on (b)(6) 2017 due to the articular surface of the proximal metaphyseal bone of the ulna collapsing around the plate and screws construct leading to intra-articular penetration and a malunion.The original construct included one (1) variable angle (va) locking compression plate (lcp) olecranon plate, three (3) 3.5 mm self-tapping cortex screws, three (3) 2.7 mm va locking screws and one (1) 2.7 mm metaphyseal independent lag screw that lead to the three (3) 2.7 mm va locking screws.The initial surgery to implant the plate and screw construct was conducted on an unknown date.Subsequently, the articular surface of the bone collapsed causing pain to the patient, and thus led to the entire plate and screws construct to be removed.All hardware was removed intact and as per the surgeon, the hardware not broken, damaged or deficient upon removal.It was also reported that a synthes radial head construct was also initially implanted in the vicinity of the plate and screws construct on an unknown date and the surgeon did not remove it since he believed that the radial head prosthesis did not contribute to the event.No additional interventions were required, and the removal surgery was completed successfully without any complications.The patient is reported to be in stable condition.This complaint involves eight (8) devices.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity # 1); radial stem (part # unknown, lot # unknown, quantity # 1).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM
• 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: 7079238
• Report Number: 2939274-2017-50127
• Device Sequence Number: 864608
• Product Code: HRS
• UDI-Device Identifier: 10886982029355
• UDI-Public: (01)10886982029355(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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: 02.107.304
• Device Catalogue Number: 02.107.304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR