MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM; SCREW, FIXATION, BONE

Model Number	02.211.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated event description provided for reporting.Tests/lab data.Medical history/preexisting condition.Additional pro-code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes rep.(b)(6).(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: it was reported that on (b)(6) 2013, the patient underwent fusion surgery on the foot and was implanted with unknown variable angle locking plates with multiple 2.7mm unknown locking screws and two (2) 4.0mm unknown cannulated screws.In late 2015, the patient began to experience discomfort and pain which attributed to his osteoarthritis and previous fracture.On (b)(6) 2016, the pain had worsened.X-rays of the foot were taken which showed several of the unknown synthes screws implanted were broken.The patient¿s clinic visits on (b)(6) 2016 and (b)(6) 2017 were due to the pain felt in the right ankle.No product was returned; the investigation was performed based upon a review of the received medical images.(b)(4).A review of the material and production records was unable to be performed as the product code and lot number of the devices were not provided.Upon review of the medical images, it cannot be confirmed that the reported implants broke due to the quality of the x-rays that were provided.The cause for the reported event of breakage was not able to be determined.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, 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 that on (b)(6) 2013, the patient underwent fusion surgery on the foot and was implanted with one (1) variable angle- locking compression plate (va-lcp) cloverleaf fusion plate, one (1) va-lcp t-fusion plate 2 hole head, one(1) 4.0mm cannulated screw long thread, one (1) va locking screw self-tapping with t8 stardrive recess 26mm, one (1) va locking screw self-tapping with t8 stardrive recess 28mm, one (1) va locking screw self-tapping with t8 stardrive recess 14mm, one (1) va locking screw self-tapping with t8 stardrive recess 20mm, one (1) va locking screw self-tapping with t8 stardrive recess 24mm, one (1) va locking screw self-tapping with t8 stardrive recess 32mm, and one (1) washer.In late 2015, the patient began to experience discomfort and pain which attributed to his osteoarthritis and previous fracture.On (b)(6) 2016, the pain had worsened.X-rays of the foot were taken which showed several of the unknown synthes screws implanted were broken.The patient¿s clinic visits on (b)(6) 2016 and (b)(6) 2017 were due to the pain felt in the right ankle.The patient met with another surgeon for a possible revision, but the surgeon refused to perform due to the risks and complications due to possible probable excessive scarification and damage to the surrounding tissue and the bone growing around the broken synthes screws.The patient experienced chronic and excruciating pain, wore a brace, on pain medication, had worsening immobility and permanently disabled.Concomitant devices reported: variable angle locking compression plate (va-lcp) cloverleaf fusion plate (part# 02.211.251, lot# unknown, quantity 1), va-lcp t-fusion plate (part# 02.211.254, lot# unknown, quantity 1), washer (part# 219.98, lot# unknown, quantity 1).This complaint involves seven (7) devices.
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 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.
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.Awareness date reported on initial report as november 30, 2018 but should have been august 13, 2019.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.
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 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 VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8898759
• Report Number: 2939274-2019-59846
• Device Sequence Number: 1413078
• Product Code: HWC
• UDI-Device Identifier: 10886982053671
• UDI-Public: (01)10886982053671
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2019

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: 02.211.032
• Device Catalogue Number: 02.211.032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 08/16/2019; 10/01/2019; 10/08/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/16/2019; 10/01/2019; 10/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR