MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	03.010.502
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a nail plate combo was being implanted on a poly trauma patient.Rfna was connected and inserted with a total knee prosthesis in.While having the nail fully inserted, the lm drill holes missed the nail.Depth gauge was inserted and bent due to malleting of depth gauge.Plate was put on the aiming arm and the fixed angle screw did not lock.A new plate was used and the plate locked.The 13mm sleeve was bent during the case as well from pushing and the entry reamer was stuck in the sleeve.Screw racks had faded numbers & screwdriver handles did not attach to the power shaft any longer and would stay on without falling off.Post op review showed that the graphic screw racks were faded and chipping, and that the handles and sleeves were not attached/were bent.The plate was dropped post op and bent/depth gauges bent.This report is for a 13.0mm protection sleeve for rafn retrograde/qc.This is report 2 of 2 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.Procode: hwc.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16215540
• Report Number: 8030965-2023-00699
• Device Sequence Number: 7435097
• Product Code: HSB
• UDI-Device Identifier: 10886982069191
• UDI-Public: (01)10886982069191
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• 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: Other Health Care Professional
• 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: 03.010.502
• Device Catalogue Number: 03.010.502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 4.5 VA-LCP CRVD COND PL/10 HOLE/230/LFT.; 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT.; AIMING ARM RADIOLUCENT.; CONNECTING SCREW.; DEPTH GAUGE FOR 3.5MM CORTEX SCREWS.; INSERTION HANDLE RADIOLUCENT.; LRG CANN HANDLE QUICK COUPLING - 12 HEX.; SCREBLADE RACK FOR FEMORAL NAIL-EX IMPLS.; UNIVERSAL CHUCK.
• Patient Sex: Unknown