MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM CANNULATED AWL

Model Number	03.010.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received, the investigation is in progress, 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 during an intramedullary (im) nailing of the femur for rotational osteotomy of the femur on (b)(6) 2020, while getting the starting point in the femur for im nail, the tip of the cannulated awl broke off.It took about 30-40 minutes to retrieved the broken piece out of the patient as the surgeon had to make a larger incision in order to access the piriformis fossa where the fragment was lodge.The procedure was successfully completed with the use of an opening reamer.Patient status was unknown.Concomitant device reported: unknown guidewire (part # unknown, lot # unknown, quantity 1).This report is for one (1) 14.0mm cannulated awl.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.Visual inspection: the 14.0 mm cannulated awl (p/n: 03.010.041, lot #: 1493547) was returned and received at us cq.Upon visual inspection, the tip of the cannulated awl was broken.The broken fragment was returned.A slight discoloration was observed on the device but has no impact on the device functionality.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed 14 mm cannulated awl awl tip.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the 14.0 mm cannulated awl (p/n: 03.010.041, lot #: 1493547).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history part: 03.010.041, lot: 1493547, manufacturing site: hägendorf, release to warehouse date: 10.May 2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 14.0MM CANNULATED AWL
• Common Device Name: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9799810
• Report Number: 2939274-2020-01164
• Device Sequence Number: 653742
• Product Code: HWJ
• UDI-Device Identifier: 10886982067142
• UDI-Public: (01)10886982067142
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 03.010.041
• Device Catalogue Number: 03.010.041
• Device Lot Number: 1493547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES
• Outcome Attributed to Adverse Event: Required Intervention