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

Model Number	394.45
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: the device was 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 on an unknown date, the holding sleeve was found in sterile processing(sp) with a schanz screw stuck inside.The wing nut broke off inside of the holding sleeve.Cannot remove schanz screw from the sleeve.The threads of the wing nut are stuck inside, but the wing was thrown away.The procedure and patient outcome were unknown.This complaint involves two (2) devices.This report is for (1) holding sleeve 55mm this report is 1 of 1 for (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.The repair technician reported the wing nut is broken off inside of holding sleeve, shantz screw is stuck.The broken piece of the wing nut was removed and the shantz screw, the wing nut was replaced.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: wing screw.The item was repaired per the inspection sheet, passed synthes final inspection on 08-jun-2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot: as per (b)(4), 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.

• Brand Name: HOLDING SLEEVE 55MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12025647
• Report Number: 2939274-2021-03048
• Device Sequence Number: 17207723
• Product Code: FZX
• UDI-Device Identifier: 10886982199737
• UDI-Public: 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 1938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 SCHANZ SCR BLUNTED TROCAR POINT 200