MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Catalog Number 4200355042

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that during a gamma nail surgical procedure, it was noted that the drill bit broke.It was further reported that the drill bit used was reprocessed.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Event Description

It was reported that during a gamma nail surgical procedure, it was noted that the drill bit broke.It was further reported that the drill bit used was reprocessed.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6; the reported drill bit involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product engineering who concluded that markings on the cutting surfaces are consistent with metal contact during use.There was a break at the proximal end of the shaft/wear markings, consistent with frictional contact while rotating were also observed.It is possible that metal contact along with the application of a bending moment while in use could cause the part to fail.Furthermore, as originally reported, the part was reported to have been reprocessed.The product device label #4200-355-737 rev.B contains a warning symbol contained in the expanded content label 0036-724-000 rev.P "do not reuse".The expanded content label also contains the warning symbol "do not use excessive force".The instructions for use(ifu) for the associated driver #4100-355-000 rev.Aa contains the following warnings; "do not reuse, reprocess, or repackage a single use device.A single use device is intended for a single use only.Reuse may create a serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure." "caution: excessive pressure can damage either the drill bit or driver.".

• Brand Name: 4.2MM RADIOLUCENT DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9163075
• MDR Text Key: 161445338
• Report Number: 0001811755-2019-03188
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• 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
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 4200355042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1