MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TEMPORARY FIXATION PIN; TAP, BONE

Catalog Number	03.161.057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 during anterior spinal fusion, the patient underwent removal of the temporary fixation pin on (b)(6) 2018.During the removal, the pin broke off.The surgeon used a vise-grip pliers and a screw removal bit to grab the broken pin but the surgeon could not remove it from the patient.The device was left in the patient.The plate was secured using all four screws with the broken temporary pin left in the vertebral body.Patient status was unknown.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed.No other additional information provided.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.Relevant tests and concomitant medical products were 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.
Event or Problem Description
Unknown quantity of unanticipated x-rays were taken during the procedure.Fragments were generated from the breakage of the temporary pin, and the broken pin could not be removed.Concomitant devices reported: ti antegra(tm) plate one level lumbar/43mm (part 04.102.143, lot unknown, quantity 1).

• Brand Name: TEMPORARY FIXATION PIN
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7494934
• Report Number: 2939274-2018-52077
• Device Sequence Number: 13781629
• Product Code: HWX
• UDI-Device Identifier: 10705034711720
• UDI-Public: (01)10705034711720
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 03.161.057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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