MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL LATARJET CC STEP DRILL 3.2MM; SURGICAL HAND DRILL

Catalog Number	285240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
Customer report: during a latarjet experience, during the surgery, it was occured a breakage of a coracoid drill bit.The medical device was in contact with the patient.The surgery didn't stop and there wasn't a change of the technical surgery.A new drill bit was used in another ancillary.No consequence for the patient.The delay for the surgery was 2 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional 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 dfa.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.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.The complaint device was received and evaluated.Visual inspection under magnification reveals that the weld at the drill tip broke leading to this failure.This complaint can be confirmed.A likely cause may have been exerting excess force or accidentally hitting bone during procedure.This failure can be attributed to user technique.However, we cannot discern a definitive root cause for the reported failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no complaints for this lot of devices that were released to distribution.At this point, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).
Additional 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.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 udi:(b)(4).
Event or Problem Description
It was reported during a latarjet experience surgery a coracoid drill bit broke.The medical device was in contact with the patient.The surgery didn't stop and there wasn't a change of the technical surgery.A new drill bit was used in another ancillary.There was no consequence for the patient.A two (2) minute surgical delay was reported.Additional information from affiliate received on 09april2018: the fragment of the broken device was removed from the patient; there was no consequence for the patient.Additional information from the affiliate received on 16april2018: it is unknown how the fragments of the device were retrieved.The procedure was completed using a similar/like device; the alternatives were readily available.It is unknown if there were any procedural or patient anatomy factors which may have contributed to the breakage.It is unknown if there is any addition surgical intervention planned.

• Brand Name: LATARJET CC STEP DRILL 3.2MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7434016
• Report Number: 1221934-2018-50469
• Device Sequence Number: 13781555
• Product Code: LXH
• UDI-Device Identifier: 10886705017942
• UDI-Public: 10886705017942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 285240
• Device Lot Number: 15B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 09/07/2018; 04/16/2018; 10/16/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 10/05/2018; 10/25/2018; 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1