MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.418
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product code: hsb.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.Product was not returned.Based on the information available, 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.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the aiming arm and protection sleeve missed the two (2) distal nail holes in multiloc nail.This was discovered after the two (2) titanium locking screws were implanted.On radiographic review, the two (2) titanium locking screws were in the bone but not in the nail.The surgeon removed the two (2) titanium locking screws.Two (2) new screws were inserted into the nail via freehand targeting technique.It was suspected that the aiming arm came loose during the nail insertion which cause the mal-alignment.The screw holes targeted as planned on the back table during a practice test.There was a surgical delay of ten (10) minutes.Procedure outcome was successfully completed.Patient outcome was unknown.This complaint involves five (5) devices.This report is for one (1) 4.0mm ti locking screw w/t25 stardrive 28mm for im nails.This report is 4 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Investigation summary: product was not returned.All items functioned correctly after post surgical inspection.Device was used for treatment, not diagnosis.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS
• 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: 8344434
• Report Number: 2939274-2019-56485
• Device Sequence Number: 11289095
• Product Code: HWC
• UDI-Device Identifier: 10886982085306
• UDI-Public: (01)10886982085306
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• 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): 01/25/2019

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: 04.005.418
• Device Catalogue Number: 04.005.418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR