MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME HALF RING; SURGICAL RETRACTION SYSTEM MOUNTING FRAME, REUSABLE

Model Number	387.337
Medical Device Problem Codes	Compatibility Problem (2960); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the customer that during testing preoperatively to an unknown procedure on (b)(6) 2022, it was observed that the screws on two synframe half ring devices were stripped and could not be tightened down.There were no adverse patient consequences reported.No additional information was provided.This complaint involves two devices.
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.H3, h4, h6 investigation summary service and repair evaluation: a shr was performed on the serviceable device and it was found that the device was manufactured on 21-may-2007.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.The customer reported the screws of synframe half ring were stripped and could not tighten down.The repair technician reported the other half of ring is non functional, product is being scrapped.Non functional item is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Device history a shr was performed on the serviceable device and it was found that the device was manufactured on 21-may-2007.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: 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: SYNFRAME HALF RING
• Common Device Name: SURGICAL RETRACTION SYSTEM MOUNTING FRAME, REUSABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14469028
• Report Number: 2939274-2022-01861
• Device Sequence Number: 17314927
• Product Code: LXH
• UDI-Device Identifier: 10705034771069
• UDI-Public: 10705034771069
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 387.337
• Device Catalogue Number: 387.337
• Device Lot Number: 1642020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 06/13/2022; 06/15/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/14/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNFRAME HALF RING
• Patient Sex: Unknown