MAUDE Adverse Event Report: SYNTHES GMBH HANDLE-MEDIUM MINI-QUICK-COUPL; SCREWDRIVER

Catalog Number 311.012

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that handle-medium mini-quick-coupl was in assembled condition.The reported condition of loose and unable to assemble/disassemble remains unverified.Review of provided photos shows that device is in assembled condition.Without having device for evaluation and functional test performed on it, potential cause of event remains undetermined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the handle-medium mini-quick-coupl would not contribute to the complained device issue.Based on the investigation findings, potential cause cannot be established and 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 depuy synthes 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.A device history record (dhr) review or manufacturing records evaluation (mre) was not possible because lot code provided is not a valid finished goods lot number.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 synthes reports an event in colombia as follows: it was reported that during a procedure on (b)(6) 2023, the sleeve of the toothed anchor screwdriver was passed with the 1.3mm screws, and when the doctor began to turn to enter the screw, the handle was released and remained in two parts.The surgery was delayed for a few seconds while the handle was tightened.The surgery was completed successfully after the two parts were tightened.The two parts were not fixed and were a little loose, but it allowed placement of the screws without inconvenience.This report involves one handle-medium mini-quick-coupl.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE-MEDIUM MINI-QUICK-COUPL
• Type of Device: SCREWDRIVER
• 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: 17913079
• MDR Text Key: 325401969
• Report Number: 8030965-2023-12848
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819019218
• UDI-Public: (01)07611819019218
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.012
• Device Lot Number: BTB_DUMMY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA
• Patient Sex: Male