MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE STABILIZATION DRBT *EA; SURGICAL HAND DRILL

Model Number	211033
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
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.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by sales rep via complaint submission tool that the lupine drill guide tip broke off while doctor was drilling into the glenoid.The lupine drill tip was left in the glenoid under lupine implant.No surgery delay.The device was discarded.Additional information provided by the affiliate reported the event occurred during a bankart procedure and a lot number is not known.It was also reported the broken piece of the bit is not going to removed form the patient and the case was completed with a like device.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: a1: the patient identifier was inadvertently missed on the initial report: (b)(6).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10590855
• Report Number: 1221934-2020-02762
• Device Sequence Number: 2627427
• Product Code: HTW
• UDI-Device Identifier: 10886705001453
• UDI-Public: 10886705001453
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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 Model Number: 211033
• Device Catalogue Number: 211033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1