MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3® Ø4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13203042

Device Problems Break (1069); Device Damaged by Another Device (2915)

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

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During gamma3 surgery, the drill broke because the drill striked to the nail.The fragment was removed with the pliers.

Manufacturer Narrative

Evaluation revealed the drill, ao small gamma3® ø4.2x300mm to be the subject product.No further associated products were reported.Review of the inspection records revealed no discrepancies.The item returned was documented as faultless prior to distribution.As the item had been in use for more than 11 years, we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.During investigation no material, design or manufacturing related issues were found.The cutting edges of the drill were in a very bad condition.They were significantly damaged.The drill was not sharp anymore.The use of a blunt drill requires unintended high forces to achieve a drilling progress at all.In addition, the risk of necrosis due to excessive heat development increases.The drilling spiral was completely sheared off at the level of approx.25 mm from the tip.Appearance of the breakage surfaces, the course of the breakage line as well as the absence of plastic deformation suggested that the drill broke in a sudden manner; it is not unlikely that drilling under misalignment and/ or bending forces in combination with high force application due to the bad cutting performance had led to the final breakage of the drill.In this case the drill had hit the nail leading to the breakage of the drill.Based on the above facts it can be ascertained that the root cause was not related to a deficiency of the device, but was rather linked to an inadequate handling by the user.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

During gamma3 surgery, the drill broke because the drill struck the nail.The fragment was removed with the pliers.

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2X300MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5505498
• MDR Text Key: 40669945
• Report Number: 0009610622-2016-00128
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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: 13203042
• Device Lot Number: KBX043745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other