MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø13 CANN L290 3FLUTE F/QC NO.; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 351.270S

Device Problem Break (1069)

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

Event Date 11/17/2022

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.Additional product codes: gfa,hsz and hwe complainant part is not expected to be returned for manufacturer review/investigation.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo revealed that the drill bit ø13 cann l290 3flute f/qc no.Had broken from the proximal tip, fragment is visible in the evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the drill bit ø13 cann l290 3flute f/qc no.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 australia as follows: it was reported on (b)(6) 2022, that the surgeon was performing a nailing procedure using the adolescent lateral femoral nail and broke the entry reamer.He broke the attachment that¿s connected to the chuck.This is due to surgeon misuse by continuing to push the reamer in the bone beyond the point where the reamer stop has reached the bone.There was no surgical delay.The procedure was successfully completed.Patient status/ outcome / consequences :no.This report is for one (1) drill bit ø13 cann l290 3flute f/qc no.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRILL BIT Ø13 CANN L290 3FLUTE F/QC NO.
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• 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: 15968495
• MDR Text Key: 308481891
• Report Number: 8030965-2022-10979
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819384385
• UDI-Public: (01)07611819384385
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• 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: 351.270S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/13/2022
• 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
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 58 KG