MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.968S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Product code: 04.033.968s, lot#: l974849, manufacturing site: (b)(4), release to warehouse date: 31.Aug.2018, expiry date: 01.Aug.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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) 2020 when putting in the proximal locking screw through the guide, the drill bit hit the nail on the first approach.It appeared that the soft tissue was bound on the sleeve and caused the drill bit to hit the nail.The surgeon readjusted the incision and the drill bit went through the nail with ease as well as did the screw.The nail and the handle were tested prior to nail insertion to make sure that the sleeves lined up correctly.There was no surgical delay and no fragments generated.The surgery was completed successfully without patient consequence.Concomitant device: unknown proximal locking screw (product# unknown, lot# unknown, qty 1).This report is for one (1) 9 mm / ti cann frn / gt 380mm / right - sterile.This is report 1 of 5 for (b)(4).

• Brand Name: 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11139585
• Report Number: 2939274-2021-00111
• Device Sequence Number: 4043036
• Product Code: HSB
• UDI-Device Identifier: 10886982272232
• UDI-Public: 10886982272232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.968S
• Device Catalogue Number: 04.033.968S-US
• Device Lot Number: L974849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING.
• Patient Age: 11 YR