MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.507.002S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent orif for facial fracture on (b)(6) 2024.The thread reduction tool broke during the procedure.It was discarded in the sharps bin.
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.H11 additional narrative: added: b5, d4 (expiry date), h4, h6 health effect - impact code corrected: d4 (primary udi number).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
Additional information was received states that there was a surgical delay of 15 minutes.Surgery ended as anticipated and the procedure was completed successfully.There were fragments generated.
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.Manufacturing location: supplier: (b)(4)/ final inspection, packaging and sterilization by: monument, release to warehouse date: 06-mar-2023 , expiration date: 31-jan-2032, part number: 03.507.002s, 2.4mm theaded reduction tool self-drilling 78mm hex-sterile , lot number: 3148p50 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.This lot was reworked for incorrect packaging configuration.After rework, all parts were determined to be acceptable.Inspection sheet, incoming final inspection, ns028194 rev e met all inspection acceptance criteria.Certificate of conformance received from precision edge dated 23-jan-2023 was reviewed and determined to be conforming.Heat treat specified at 48 hrc minimum; certified at 54.0 hrc.Packaging label log (pll) lppf rev f, lmd rev b were reviewed and determined to be conforming.Scn 24943 supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection, packaging or release that would contribute to this complaint condition.(b)(6) 2024: dhr reviewed this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 20514130
• Report Number: 8030965-2024-13096
• Device Sequence Number: 18273825
• Product Code: LXH
• UDI-Device Identifier: 10887587014166
• UDI-Public: (01)10887587014166(10)3148P50
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,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 Catalogue Number: 03.507.002S
• Device Lot Number: 3148P50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 11/08/2024; 11/22/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/07/2024; 11/13/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown