MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 HOLES/LEFT; PLATE,FIXATION,BONE

Model Number	02.118.209
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2019, the surgeon scheduled a removal of a variable angle anterlateral distal tibia plate on (b)(6) 2019 due to pain.It is unknown if there was surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) 2.7/3.5mm va-lcp anterolateral distal tibia pl/10 holes/left this is report 1 of 2 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.Implanted in 2015; exact date is unknown.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 the original surgery was performed on an unknown date in 2015 to treat the distal tibia fracture.Hardware was removed on (b)(6) 2019 due to patient¿s pain on anterior side.All bones healed and there was no sign of any infection.Plates and screws were difficult to remove and 2 of the 2.7mm va locking screws broke during hardware removal and remained in patient.This report captures hardware removal due to postop pain, while related complaint: (b)(4) captures intraoperative issue of difficulty in hardware removal.This is report 1 of 4 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.Device history records review was completed for part: 02.118.209, lot: 9897322.Manufacturing location: emira, manufacturing date: sep 16, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Actual device was not returned.No product issues/defects were identified in the x-ray review.Relevant drawings were reviewed.No product design issues or discrepancies were observed during this investigation.A definitive assignable root cause for the reported condition of pain could not be determined based on the provided information.This complaint was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 HOLES/LEFT
• 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: 8345182
• Report Number: 2939274-2019-56499
• Device Sequence Number: 11243701
• Product Code: HRS
• UDI-Device Identifier: 10886982038449
• UDI-Public: (01)10886982038449
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.118.209
• Device Catalogue Number: 02.118.209
• Device Lot Number: 9897322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/13/2019; 03/26/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/11/2019; 03/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention