MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 8H/RT/157MM; PLATE, FIXATION, BONE

Model Number	02.107.408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-code: hwc.A review of the device history record has been requested.Device history lot- part number: 02.107.408.Lot number: h138481.Part manufacturing date: 06 july 2016.Manufacturing site: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.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 x-articlr proximal ulna pl 8h/rt/157mm non-sterile product was processed through the normal manufacturing and inspection operations with no rework or non-conformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot met all specifications with no issues documented that would contribute to this complaint condition.Device history batch null, device history review this 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.Investigation summary background: it was reported that on (b)(6) 2019, the patient underwent removal of variable angle locking compression plate due to breakage at the 3rd most proximal screw hole.The plate and unknown screws were originally implanted on (b)(6) 2018.There were no fragments generated from the broken device.Broken fragments were completely removed.There was a removal then re implantation of a longer plate, same model.It was unknown if there was a surgical delay.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown variable angle locking screws (part #: unknown, lot #: unknown, quantity #: unknown), unknown cortex screws (part #: unknown, lot #: unknown, quantity #: unknown).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the 2.7 mm/3.5 mm va-lcp x-articlr proximal ulna pl 8h/rt/157mm (part # 02.107.408, lot # h138481) was returned and received at us cq.Upon visual inspection, it was observed that device was observed to be broken.The implant displayed wear/scratches from explanation.No other issues were identified with the returned components of the device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.The device received is broken.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for 2.7 mm/3.5 mm va-lcp x-articlr proximal ulna pl 8h/rt/157mm (part # 02.107.408, lot # h138481) was observed to be broken.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on (b)(6) 2019, the patient underwent removal of variable angle locking compression plate due to breakage at the 3rd most proximal screw hole.The plate and unknown screws were originally implanted on (b)(6) 2018.There were no fragments generated from the broken device.Broken fragments were completely removed.There was a removal then reimplantation of a longer plate, same model.It was unknown if there was a surgical delay.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown variable angle locking screws (part #: unknown, lot #: unknown, quantity #: unknown), unknown cortex screws (part #: unknown, lot #: unknown, quantity #: unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 8H/RT/157MM
• 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: 8866380
• Report Number: 2939274-2019-59547
• Device Sequence Number: 14002329
• Product Code: HRS
• UDI-Device Identifier: 10886982029423
• UDI-Public: (01)10886982029423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.107.408
• Device Catalogue Number: 02.107.408
• Device Lot Number: H138481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 120