MAUDE Adverse Event Report: SYNTHES GMBH UNK - GUIDES/SLEEVES/AIMING: SLEEVE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported that during surgery on (b)(6) 2023, the frn 10x400 l gt was inserted into a heavier patient.When inserting the nail, there was resistance.Once the nail was fully inserted, green triple sleeves were inserted through the jig and malleted.The inner trocar ended up bending, so it was taken out and then drilled.The drill bit hit the nail, so a new triple sleeve was inserted.The drill bit hit the nail again.The nail was removed, and a tfna was inserted instead with no issues.The surgery was successfully completed without any delay.There was no patient consequence.This report involves one unk - guides/sleeves/aiming: sleeve.This is report 5 of 5 for (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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown guides/sleeves/aiming: sleeve/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

• Brand Name: UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17542139
• MDR Text Key: 321091745
• Report Number: 8030965-2023-10260
• Device Sequence Number: 1
• Product Code: FXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• 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: 10 / TI CANN FRN / GT 400 / LEFT - SILE; 4.2MM TROCAR 210MM; 4.2MM TROCAR 210MM; UNK - DRILL BITS: TRAUMA