MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PUSH-PULL REDUCTION DEVICE; GUIDE

Catalog Number	324.024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 162 cms.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter¿s first name, facility name, address and phone number is not provided for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent an open reduction internal fixation (orif) of ankle on (b)(6) 2018.The surgeon used a push-pull reduction device to compress plate to the bone.While tightening with pliers, the threaded tip of the push-pull reduction device snapped, leaving a portion inside the patient¿s bone.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity 1), unknown pliers (part # unknown, lot # unknown, quantity 1).This report is for one (1) push-pull reduction device.This is report 1 of 1 for complaint (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 lot number is unavailable as lot number was reported to be worn off.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 device lot number was worn off.
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.Additional information provided.Reporter email address 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
The surgical procedure was successfully completed with no surgical delay.Concomitant devices: plate 6-hole variable angle anterolateral distal tibial plate (part: unknown, lot: unknown, quantity: 1), non-synthes pliers (part: unknown, lot: unknown, quantity: 1).
Event or Problem Description
Further, it was reported that there was no additional medical intervention required.
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.Additional narrative: event: updated.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: PUSH-PULL REDUCTION DEVICE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7820855
• Report Number: 2939274-2018-53500
• Device Sequence Number: 11110465
• Product Code: FZX
• UDI-Device Identifier: 10886982190963
• UDI-Public: (01)10886982190963
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 324.024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/25/2018; 09/25/2018; 10/04/2018
• 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: 51 YR
• Patient Weight: 56