MAUDE Adverse Event Report: SYNTHES GMBH 3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG; PLATE, FIXATION, BONE

Model Number	02.104.026
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on unknown even date that post op inspection occurred graphic case had white sandy due to volume of usage and peeling of graphic case.Short power shafts were warped due to usage, and kept stripping screws.Connecting element threads were stripped after usage.Plates were bent after wash from cspd.No patient and procedure outcome and no surgical delay reported because it is a post of event.This report is for one (1)3.5 lcp x-artc dstl hum pl 6h/lt 158 lg.This is report 5 of 6 (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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The initial reporter is a j&j sales representative.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: 3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG
• Common Device Name: PLATE, FIXATION, BONE
• 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: 15792795
• Report Number: 8030965-2022-09777
• Device Sequence Number: 4546498
• Product Code: HRS
• UDI-Device Identifier: 10886982029126
• UDI-Public: (01)10886982029126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K031178
• 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: 02.104.026
• Device Catalogue Number: 02.104.026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/14/2022
• 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: 1/3 INS TRAY DSTL RAD RETRCTRS/HK/ELVTRS.; 1/3 INSTR TRAY DSTL RAD FRCP & PLIERS.; 2/3 INSTR TRAY FOR LCP & VA DSTL RAD S.; 3.5 LCP X-ARTC DSTL HUM PL 10H/RT 230 LG.; BENDING PLIERS-SMOOTH JAWS FOR MINI PLS.; CONNECTING SCREW.; RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25.
• Patient Sex: Unknown