MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø3.2X145MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700358
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2018
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 hospital reported the following event : "(b)(6) patient, hospitalized for osteosynthesis of the right humerus.The wick used for distal locking of the humeral nail broke in the patient's body and his extremity could not to be removed.Two other strands (different society) were also broken during the same procedure (our aa references (b)(4)).The device has been retained for expertise".Clinical consequences noted: the ends of the broken bits remained in the patient's body are not known.Extension of the intervention time.
Additional Manufacturer Narrative
The reported event that drill bit ø3.2x145mm ao fitting was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate mechanical force which had been applied during drilling.The device inspection revealed the following: the returned drill bit is indeed complately broken off as complaint.The close up views, done by the microscope, clearly indicate that inadequate mechanical force had been applied during drilling as the flutes and the tip are so badly damaged / deformed.Marks on the front part of the drill bit indicate inadequate angulation during drilling.Note that the drill bit was manufactured in dec.2006 and therefore has been in use over 12 years.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 or Problem Description
The hospital reported the following event : " 44-year-old patient, hospitalized for osteosynthesis of the right humerus.The wick used for distal locking of the humeral nail broke in the patient's body and his extremity could not to be removed.Two other strands (different society) were also broken during the same procedure (our aa references 2018/1088).The device has been retained for expertise." clinical consequences noted: the ends of the broken bits remained in the patient's body are not known.Extension of the intervention time.

• Brand Name: DRILL BIT Ø3.2X145MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8182754
• Report Number: 0008031020-2018-01077
• Device Sequence Number: 1900460
• Product Code: LXH
• UDI-Device Identifier: 04546540110251
• UDI-Public: 04546540110251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 700358
• Device Lot Number: M18176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/19/2018
• 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