MAUDE Adverse Event Report: SYNTHES GMBH LCP UNIV-DRILL-GUIDE 4.5/5; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	323.500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2024 that (323.500) drill guide cap was broken, can not locate, will not function without, belongs to tomofix and do not have a substitute.(310.990) countersink is rusted, not damaged or chipped.Rust is becoming more prominent.(03.045.022) 4.2 drillbit has not been used but are rusted.All items have been found, and have not been used.There was no patient involvement.This report is for one (1) lcp univ-drill-guide 4.5/5 this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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.
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.B5: event description updated.D9: device returned.H3, h4, h6: service and repair evaluation: the customer reported 323.500, lcp univ-drill-guide 4.5/5 was broken, can not locate, will not function without, belongs to tomofix and do not have a substitute.The repair technician reported device has missing components, shows damage from exterior.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: replacement retaining cap.The item was repaired per the inspection sheet, passed synthes final inspection on 01-feb-2024 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.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 review (dhr): part # 323.500.Lot # l701569.Manufacturing site: werk bettlach.Release to warehouse date : 15 dec 2017.Expiration date: n/a.Supplier: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.G1: manufacture site updated.
Event or Problem Description
The issues were noted preoperatively.The items had not been used.They had not been holding up after washes.

• Brand Name: LCP UNIV-DRILL-GUIDE 4.5/5
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18617965
• Report Number: 8030965-2024-01678
• Device Sequence Number: 2406277
• Product Code: FZX
• UDI-Device Identifier: 07611819248502
• UDI-Public: (01)07611819248502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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 Catalogue Number: 323.500
• Device Lot Number: L701569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2016
• 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: COUNTERSINK LRG L180 F/CORTSCR Ø4.5; DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG; DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG
• Patient Sex: Unknown