MAUDE Adverse Event Report: SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

Catalog Number	03.019.025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on january 28, 2025 the device split into two pieces when trying to release multiloc screws into the patient.The round silver ¿plunger¿ broke off.Surgeon was able to work around it after the part broke.This was involved with 3 of the multiloc screws.This caused a delay to the case which resulted in having to "makeshift" the device to continue.The patient status/outcome/consequences is unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial report, a follow-up report 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.H11 additional narrative: added: b5 corrected: h6 (health effect - impact code & health effect - clinical code).H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: the product was not returned to medtech orthopaedics; however photos were provided for review.The photo investigation revealed that scrwdrvr 4.5 ti multilc scrs/slf-ret/330, the photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the scrwdrvr 4.5 ti multilc scrs/slf-ret/330 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that the patient outcome was everything came out fine as stated.No allegations against screws.

• Brand Name: SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
• Common Device Name: SCREWDRIVER
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 21337868
• Report Number: 8030965-2025-01416
• Device Sequence Number: 3772424
• Product Code: HXX
• UDI-Device Identifier: 10886982069641
• UDI-Public: (01)10886982069641
• 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

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: 03.019.025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown