MAUDE Adverse Event Report: STRYKER GMBH 3.0 ASNIS MICRO DOUBLE DRILL GUIDE 1.2/2.1MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-30009
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
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
As reported: "the end of the drill sleeve (purple) close to the plate has broken off.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: by doing the visual inspection, we can confirm the incident's problem.The end of the drill bit broke off and got stuck inside the drill guide.The microscopic pictures show the difference between a prototype drill guide from the inside and the drill guide that has a broken drill bit inside and that there is an abnormal element stuck inside the hole of the drill guide.By making the parallel of the conforming prototype device and the defective device, we can see that the latter is not functional.This not functional has therefore probably led to a reduction of the bore diameter (cf.Dimensional inspection).Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.A review of the device history was not possible because the lot number was not communicated.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.Based on the above investigation, the root cause of the failure is user related.The breakage of the drill guide happened due to a combined torsional and bending overload.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the end of the drill sleeve (purple) close to the plate has broken off.".

• Brand Name: 3.0 ASNIS MICRO DOUBLE DRILL GUIDE 1.2/2.1MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15257227
• Report Number: 0008031020-2022-00398
• Device Sequence Number: 6688496
• Product Code: LXH
• UDI-Device Identifier: 04546540534477
• UDI-Public: 04546540534477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 45-30009
• Device Catalogue Number: 45-30009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown