MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM-STER; PLATE, FIXATION, BONE

Model Number	02.107.002S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as (b)(6) cm.Additional patient identifier: (b)(6).Date of event: unknown.Additional product code: hwc.Date of implant reported as (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 hardware removal was performed on (b)(6) 2017 due to patient complaints of prominence of the shaft portion of a proximal ulna plate.The original procedure was performed on an unknown date in (b)(6) 2017.The removed hardware included one 2.7mm/3.5mm variable angle locking compression plate (va-lcp) proximal olecranon plate and six screws, all intact and removed without incident.No reported surgical delays.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 3.5mm cortex screw self-tapping 24mm (part 204.824, lot number unknown, quantity 1); 2.7mm variable angle locking screw self taping with t8 stardrive recess 56mm (part 02.211.056, lot number unknown, quantity 1); 2.7mm variable angle locking screw self taping with t8 stardrive recess 22mm (part 02.211.022, lot number unknown, quantity 1); 2.7mm variable angle locking screw self taping with t8 stardrive recess 18mm (part 02.211.018, lot number unknown, quantity 1); 2.7mm variable angle locking screw self taping with t8 stardrive recess 16mm (part 02.211.016, lot number unknown, quantity 1); 3.5mm locking screw self taping with stardrive (tm) recess 56mm (part 212.108, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part# 02.107.002s lot# h268692 part mfg date: 24 janurary 2017 mfg location: (b)(4).Part expiration date: 31 december 2026 dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm va-lcp proximal olecranon pl 2h/rt/73mm-sterile 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 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/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM-STER
• 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: 7157587
• Report Number: 2939274-2018-50012
• Device Sequence Number: 13653471
• Product Code: HRS
• UDI-Device Identifier: 10886982029232
• UDI-Public: (01)10886982029232(17)261231(10)H268692
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/04/2017

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: 02.107.002S
• Device Catalogue Number: 02.107.002S
• Device Lot Number: H268692
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/29/2018
• 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 Weight: 87