MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER SHORT XL25; SCREWDRIVER

Catalog Number 03.045.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that (b)(6) 2024, the patient underwent an rfna implant surgery for peri-tka fracture.While distal side hole was shaved off, drill bit interfered with the nail.While proximal side hole was shaved off, drill bit interfered with the nail.While hammering, pad¿s knob came off from aiming device.When screwdriver self-retaining xl25 and retention pin tried to be inserted, screw did not grip.When endcap was tried and being inserted, endcap did not grip, the screwdriver self-retaining xl25 and retention pin were used, and they were successfully inserted.Retention pin broke off and its breakage remained temporarily.No further information is available.This event is related to (b)(4).This report is for one (1) scrdriver short xl25 this is report 3 of 5 for complaint (b)(4).

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.H3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: SCRDRIVER SHORT XL25
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF; im bifang 6; hägendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19084209
• MDR Text Key: 340018651
• Report Number: 8030965-2024-04820
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07612334167804
• UDI-Public: (01)07612334167804
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 03.045.003
• Device Lot Number: 237P667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR F/NAILS Ø5 L32 XL25; RETENTION PIN SHORT XL25; UNK - DRILL BITS: TRAUMA; UNK - END CAPS; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAILS: RFNA; UNK - REAMERS; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING