MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE Ø2.5MM, NON-LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 705022

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

The drill bit stuck into the drill guide and broke.Surgical delay of a few minutes.An exactly time of delay is not reported.

Manufacturer Narrative

The reported event that drill guide ø2.5mm, non-locking was alleged of 'component/device stuck' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during use.The device inspection revealed the following: it is clearly visible, as the returned drill bit got badly bent, that far too much mechanical force was applied during drilling and finally resulted in the breakage of the front part of the drill shaft.Note that the reminding part of the drill bit is still completely wedged in the drill guide.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The drill bit stuck into the drill guide and broke.Surgical delay of a few minutes.An exactly time of delay is not reported.

• Brand Name: DRILL GUIDE Ø2.5MM, NON-LOCKING
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7383208
• MDR Text Key: 104035431
• Report Number: 0008031020-2018-00258
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 705022
• Device Lot Number: K03108A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other