MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL DRILLPN W/EYE .094X14" *EA; SURGICAL HAND DRILL

Catalog Number	219321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 lot number was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) via fax that during a knee ligamentoplasty when carrying the patient's ligament, the surgeon discovered that the extremity of the acl drill pin with eyelet was broken.The x-rays confirmed the presence of the broken piece at the end of the femoral tunnel.The fragment was not extracted and remained inside the patient's knee.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device available for use to complete the surgery.There was patient involvement.It was not reported if there was a prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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).The lot number is unknown.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8655460
• Report Number: 1221934-2019-57252
• Device Sequence Number: 19290671
• Product Code: NBH
• UDI-Device Identifier: 10886705005727
• UDI-Public: 10886705005727
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 219321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention