MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 55MM; GUIDE, SURGICAL, INSTRUMENT

Model Number	394.45
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a j&j sales representative.A product investigation was conducted.Service and repair evaluation: the customer reported that the wing screw was broken in holding sleeve.The repair technician reported the device is missing the wing screw.Missing parts is the reason for repair.The cause of the issue is missing parts.The following part was replaced: wing screw.The item was repaired per the inspection sheet, passed synthes final inspection on 03-aug-2021 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.No design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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 on unknown date, during an unknown procedure the wing screw was broken in holding sleeve.During manufacturer's investigation of the returned holding sleeve 55mm it was observed that device cannot be assembled.This report is for one (1) holding sleeve 55mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: HOLDING SLEEVE 55MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12313761
• Report Number: 2939274-2021-04619
• Device Sequence Number: 11722397
• Product Code: FZX
• UDI-Device Identifier: 10886982199737
• UDI-Public: (01)10886982199737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 394.45
• Device Catalogue Number: 394.45
• Device Lot Number: 9584965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1