MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM; PLATE,FIXATION,BONE

Model Number	02.107.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional classification code: hwc complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient code: (b)(4) surgical intervention required to remove protruding plate.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 had a open reduction internal fixation for a acute fracture of the right olecranon on (b)(6) 2018.The patient went to surgeons office on (b)(6) 2018 with a portion of the plate protruding through the skin.Surgeon stated he thought the split rubbing on the plate is what wore out the skin.The patient underwent surgery the same day to remove the hardware.The fracture appeared healed.No new fixation was needed according to the surgeon.All hardware (1 plate and 6 screws) was removed intact without delay.Concomitant product: qty 6, unknown screw(s) this is report 1 of 1 for (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.Dhr review was completed.Part# 02.107.202 , lot# h454683 , mfg location: elmira synthes usa , mfg date: 26 september 2017 , expiration date: n/a, noted nonconformances: n/a.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 olectranon plate 2h/rt/90mm 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Date of report , date rec¿d by mfr : date reported on initial report was 3/24/2018.Correct date should have been 3/23/2018.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 OLECRANON PL 2H/RT/90MM
• 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: 7430999
• Report Number: 2939274-2018-51697
• Device Sequence Number: 2156228
• Product Code: HRS
• UDI-Device Identifier: 10886982029263
• UDI-Public: (01)10886982029263
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 02.107.202
• Device Catalogue Number: 02.107.202
• Device Lot Number: H454683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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 Age: 19 YR
• Patient Weight: 37