MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TREPHINE ATTACHMENT 5.5MM DIAMETER

Catalog Number	03.111.025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is an unknown date in (b)(6) 2018.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unavailable.Reporter is a synthes sales consultant.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 an unknown orthopedic procedure in (b)(6) 2018, the trephine attachment 7.0mm and trephine attachment 5.5mm diameter broke off in the patient during a procedure; most of the fragments were removed, but some fragments were left inside the patient.It is unknown if there were any surgical delay.Patient outcome is unknown.This report is for a trephine attachment 5.5mm diameter.This is report 2 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.Additional narrative: event description: updated.Initial reporter information updated.Device evaluated by mfr: 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 an unknown orthopedic procedure in (b)(6) 2018, the trephine attachment 7.0mm and 5.5mm diameter broke off in the patient.Some fragments were left inside the patient.Procedure was completed successfully with no delay.Patient outcome was reported as stable.

• Brand Name: TREPHINE ATTACHMENT 5.5MM DIAMETER
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7731091
• Report Number: 2939274-2018-53114
• Device Sequence Number: 1588382
• Product Code: HWK
• UDI-Device Identifier: 10886982072245
• UDI-Public: (01)10886982072245
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 03.111.025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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