MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM TROCAR FOR RECON LOCKING; MISC, ORTHO, SURGICAL INSTRUMENT

Model Number	03.010.077
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2019, during an unknown procedure, the screws would not go through the nail that resulted to a conversion to a tfna.It is unknown if there was a surgical delay.Procedure outcome is unknown. there was no patient harm.This complaint involves nine (9) devices.This report is 3 of 9 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.Code 3191 also used to capture device failure.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
There was a surgical delay of five (5) minutes.The procedure was completely successfully.

• Brand Name: 3.2MM TROCAR FOR RECON LOCKING
• Common Device Name: MISC, ORTHO, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9350987
• Report Number: 2939274-2019-62309
• Device Sequence Number: 16217649
• Product Code: LXH
• UDI-Device Identifier: 10886982067470
• UDI-Public: (01)10886982067470
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 03.010.077
• Device Catalogue Number: 03.010.077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention