MAUDE Adverse Event Report: DEPUY MITEK LLC US SCR/WASH HEXDRV 2.5MM *EA; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	219124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
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 sales rep via cst that during an acl reconstruction procedure, it was observed that the driver tip broke while inserting the screw.It was reported that the tip was only fragment that broke and was easily removed.The case was successfully completed with another driver.There was no patient consequence or surgical delay.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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.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 received and evaluated.Visual inspection under magnification reveals that the hex section of the distal tip is broken off.The device is possibly old and heavily used.This complaint can be confirmed.It is unknown based on the information provided and the physical inspection to determine the root cause of this failure.Furthermore, no lot number was supplied which precludes conducting a batch history review.Therefore, we cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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 SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8663459
• Report Number: 1221934-2019-57289
• Device Sequence Number: 11311573
• Product Code: LXH
• UDI-Device Identifier: 10886705005420
• UDI-Public: 10886705005420
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 219124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1