MAUDE Adverse Event Report: SYNTHES GMBH PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.043.033S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
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.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.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) 2023, the wire sleeve was damaged as it was a very tight joint to try and get the protective sleeve through.The surgeon used light mallot taps to try and advance the wire sleeve down to the bone.The 3.2 wire no longer passes through the holes in the sleeve.The protection sleeve was discarded and wire sleeve damaged.Procedure was completed successfully using a 2nd set for a new wire sleeve.No fragments generated.This report is for one (1) protection sleeve/ flex/ long for nails ø 8-11mm / sterile.This is report 2 of 2 for complaint (b)(4).

• Brand Name: PROTEC SLV/ FLEX/ LG FOR NL 8-11 / -S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17080672
• Report Number: 8030965-2023-07218
• Device Sequence Number: 16687677
• Product Code: LXH
• UDI-Device Identifier: 10886982298850
• UDI-Public: (01)10886982298850
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 03.043.033S
• Device Catalogue Number: 03.043.033S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WIRE GUIDE / MULTIHOLE / LG NL 8-11.
• Patient Sex: Unknown