MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702449
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that the cannulated drill is stuck inside the drill guide.The drill snapped as the surgeon was trying to get it our of the guide.No pieces fell into the patient.5 mins surgical delay while a new set was opened.No adverse consequences.
Event or Problem Description
The customer reported that the cannulated drill is stuck inside the drill guide.The drill snapped as the surgeon was trying to get it our of the guide.No pieces fell into the patient.5 mins surgical delay while a new set was opened.No adverse consequences.
Additional Manufacturer Narrative
The reported event that cannulated drill asnis iii ø2.7mm ao fitting 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 debris that got stuck into the drill guide.Furthermore, the drill guide having been manufactured in 2007, it has been fulfilling its role properly for the past 11 years.Normal wear of the device is probably a part of the reason the reported event happened.The device inspection revealed the following: the visual inspection confirms that the two devices are stuck to each other.It is not possible, using hand force only to remove them from each other.Furthermore, as per event description, the proximal part of the drill is broken, probably due to the attempt of the hcp to remove the two device from each other.The drill guide shows various signs of usage, such as scratches, proving that it was used often during service life.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.

• Brand Name: CANNULATED DRILL ASNIS III Ø2.7MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8084081
• Report Number: 0008031020-2018-00987
• Device Sequence Number: 1771137
• Product Code: LXH
• UDI-Device Identifier: 04546540112033
• UDI-Public: 04546540112033
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 702449
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other