MAUDE Adverse Event Report: DEPUY MITEK LUPINE STABILIZATION FISHMOUTH DRGDE *EA; SURGICAL HAND DRILL

Catalog Number 213817

Device Problems Bent (1059); Metal Shedding Debris (1804)

Patient Problem Foreign Body Reaction (1868)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ udi: (b)(4).The expiration date is not currently available.

Event Description

Lupine fishmouth drill guide is bent at the end which causes the drill to make contact with the guide.This action leaves metal shavings behind and makes it difficult to get the implant down the guide.New drill guide was used to finish the case.Patient consequence? :unknown patient consequence description: metal shavings could have been left behind action taken for procedure:new drill guide was used for the remainder of the procedure with no problems is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

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.Evaluation statement: despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received for evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.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 in time, 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.Udi: (b)(4).Device evaluated by manufacturer.

• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7217317
• MDR Text Key: 98163241
• Report Number: 1221934-2018-50101
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213817
• Device Lot Number: 6D1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR