MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER/RC DRBIT ARTHRO 2.9MM; SURGICAL HAND DRILL

Model Number	211513
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
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).Investigation summary: the complaint device was received and evaluated.Upon visual observation, that the most distal tip of the drill bit was found to be slightly bent.The rest of the device shows no physical damage.Thus, the complaint can be confirmed.Excessive force by surgeon during the procedure might have contributed to the complaint condition.An mre was not performed for this part as the lot number was unknown.At this point in time, no corrective action is required, and no further action is warranted.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.
Event or Problem Description
It was reported by the affiliate via email that during a shoulder stabilization the tip of the super/rc drbit arthro 2.9mm was slightly bent.No patient consequence and no surgical delay was reported.No additional information was reported.Additional information provided by the affiliate reported a surgical delay was not reported.It was also reported the case was successfully completed with the same drill bit.The affiliate reported the drill bit was ¿blunt¿ as such, but just slightly bent on the tip.It was not significant enough for the surgeon to switch to a replacement drill bit during the case, but rather just requested it be replaced for next time.It was reported the lot number was unknown and the product is available for evaluation.
Additional Manufacturer Narrative
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.H10 additional narrative: additional information: investigation summary = > the complaint device was received and evaluated.Upon visual observation, that the most distal tip of the drill bit was found to be slightly bent.The rest of the device shows no physical damage.Thus, the complaint can be confirmed.Excessive force by surgeon during the procedure might have contributed to the complaint condition.An mre was not performed for this part as the lot number was unknown.At this point in time, no corrective action is required, and no further action is warranted.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: SUPER/RC DRBIT ARTHRO 2.9MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9808953
• Report Number: 1221934-2020-00797
• Device Sequence Number: 2788921
• Product Code: GFG
• UDI-Device Identifier: 10886705001750
• UDI-Public: 10886705001750
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 211513
• Device Catalogue Number: 211513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1