MAUDE Adverse Event Report: SYNTHES GMBH LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 323.042

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 10/25/2023

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.E3: reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent orif surgery for femoral neck fracture on proximal femoral.In the surgery, the drill sleeve in question was connected to the plate to fix the distal transverse stop with a 5.0 mm locking screw.The drill bit in question was connected to the chuck of the hospital's power tool and the surgeon started to drill.When drilling to the contralateral cortex, abnormal vibrations were detected.When the drill sleeve in question was removed from the plate, the threaded portion at the end was missing.As much debris as possible was removed and a locking screw was inserted and fixed using a screwdriver with torque.During the second drill, the connection of the drill sleeve in question (the undamaged product) was carefully checked, but the same event occurred.As with the first one, debris was removed and a locking screw was inserted.It took an extra 15 to 20 minutes to remove the debris.The surgeon used imaging to check for debris, determined there was none, and closed the wound.However, there might be a possibility that the debris are still there.After the surgery, the surgeon commented the followings.The drill did not cut as well as unusual, no matter how young the patient was.This may have caused the drill to be subjected to an unnecessarily heavy load, resulting in the damage.He wants the investigation to check if there is any possibility of deterioration in the product.Possible causes other than product: good bone quality the surgery was successfully completed.Patient status/ outcome: stable no further information is available.This report is for one (1) lcp drill sleeve 5 f/drill bits ø4.3 this is report 2 of 3 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.H3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that thread tip of the lcp drill sleeve 5 f/drill bits ø4.3 was found broken, fragment was not received for evaluation.No other issues were identified.Embedded condition of the fragment cannot be confirmed as x-ray images were not provided.A dimensional inspection for the lcp drill sleeve 5 f/drill bits ø4.3 was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the lcp drill sleeve 5 f/drill bits ø4.3 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: - lcp drill sleeve 5 for drill bits ø4.3 se_473511 rev.D (current) / rev.B (manufactured).Dimensional inspection: n/a.H4, h6 part# 323.042, lot # 9770107, manufacturing site: werk hägendorf , supplier: na , release to warehouse date: 01 feb 2016, expiration date: na.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.

• Brand Name: LCP DRILL SLEEVE 5 F/DRILL BITS Ø4.3
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18131194
• MDR Text Key: 329365427
• Report Number: 8030965-2023-14295
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819246607
• UDI-Public: (01)07611819246607
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.042
• Device Lot Number: 9770107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: LCP DRILL BIT Ø4.3 W/STOP L221 2FLUTE F/; UNK - PLATES: TRAUMA; UNK - SCREWDRIVERS: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA
• Patient Age: 60 YR
• Patient Sex: Female