MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.005.424
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: hwc.Complainant device is not expected to be returned for manufacturer review/investigation it was discarded.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: 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 an unknown date when putting unknown distal screws into the long multiloc humeral nail the 4.0mm titanium locking screws that was used was not engaging the unknown distal cortex.When the screw was exchanged for a longer screw the staff believed the screw threads were stripped out and could not engage the far cortex.No fragments generated.No surgical delay.The procedure successfully completed.No patient harm.Concomitant device reported: unk: nails: humeral (part# unknown; lot# unknown; quantity: 1).Unk: screws: nail distal locking (part# unknown; lot# unknown; quantity: unknown).Unk: screwdrivers (part# unknown; lot# unknown; quantity: 1).This complaint involves (2) devices.This report is for (1) 4.0 ti lckng scr t25 sd 34 for im nails.This repot is 1 of 2 for (b)(4).

• Brand Name: 4.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS
• 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: 11881082
• Report Number: 2939274-2021-02565
• Device Sequence Number: 3747031
• Product Code: HSB
• UDI-Device Identifier: 10886982085368
• UDI-Public: (01)10886982085368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 04.005.424
• Device Catalogue Number: 04.005.424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1