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

Model Number	285240
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).(b)(6).Associated medwatch number: 1221934-2018-50177 & 1221934-2018-50178.
Event or Problem Description
It was reported by the sales rep that two of the customer's latarjet step drill 3.2mm, one glenoid long drill bit and bristow latarjet 48mm screw top hat were dull and their latarjet bone screw retriever was bent in between cases.There was no case or patient involvement.The devices are being returned.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial and first follow-up medwatch, a second follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch number: 1221934-2018-50177 & 1221934-2018-50178.
Additional 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 additional information should become available, a supplemental medwatch will be submitted accordingly.D3, g1-2: the manufacturer contact name has been updated as (b)(4).Contact phone number and email address have been updated accordingly.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the drill tip was slightly worn.It was also observed that the laser markings were heavily faded.The device is reusable.It is possible that the device was dropped or mishandling on the drill tip during use or during reprocessing and cleaning, which would cause the drill to be dull.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, no corrective action is required and 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.

• 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 CH-24 00; SZ CH-2400
• MDR Report Key: 7275061
• Report Number: 1221934-2018-50176
• Device Sequence Number: 13706772
• Product Code: LXH
• UDI-Device Identifier: 10886705017942
• UDI-Public: (01)10886705017942(10)17B01
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2018

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 Model Number: 285240
• Device Catalogue Number: 285240
• Device Lot Number: 17B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 04/06/2018; 11/21/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/01/2018; 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1