MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS; NAIL,FIXATION,BONE

Model Number	03.010.435
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.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 product was received; 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) 2020, the compression device for suprapatellar, extractor, connecting screws and extraction screw were stripped, trocars were bent along with the wire guides, blue handle, black knob broke off, along with buttons on the side to protection sleeve.The surgeon was aggressive and over-torqued products leading to stripping and bending of products.A new set brought into the room.There were 10 minutes of surgical delay.It is unknown if the surgery successfully completed.No patient consequence.This complaint 11 devices.This report is for (1) 12.0mm protection slv straight for 8mm-11mm nails.This report is 6 of 8 for (b)(4).

• Brand Name: 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11072170
• Report Number: 2939274-2020-05699
• Device Sequence Number: 11590799
• Product Code: JDS
• UDI-Device Identifier: 10886982068767
• UDI-Public: (01)10886982068767
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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): 11/28/2020

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: 03.010.435
• Device Catalogue Number: 03.010.435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 12/24/2020
• Patient Sequence Number: 1