MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø4.3MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705042
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not yet returned.When additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
During axsos df surgery, a piece of the drill sleeve stuck into a scrub nurse's hand.The broken piece was completely removed from the hand.
Event or Problem Description
During axsos df surgery, a piece of the drill sleeve stuck into a scrub nurse's hand.The broken piece was completely removed from the hand.
Additional Manufacturer Narrative
The reported event that drill sleeve, locking 4.3mm, short was alleged of 'breakage during surgery' could not be confirmed, since the returned device is conforming to specifications, fully functional and presents no sharp edges whatsoever.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the product return for this product inquiry was received and analysed: 4 drill sleeves were returned, 3 of which have the lot number k0741ae.Those drill sleeves were inspected and none of them have any apparent broken part, or sharp edges.2 drills of catalog# 705043 were also shipped back.None of the two drills is broken, but one of them shows significant signs of wear, as circular traces deforming the material can be noticed all over the length.Both the drills can go through all 4 drill sleeves without any problems.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: DRILL SLEEVE, LOCKING Ø4.3MM, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7605700
• Report Number: 0008031020-2018-00466
• Device Sequence Number: 16618867
• Product Code: LXH
• UDI-Device Identifier: 07613327083620
• UDI-Public: 07613327083620
• Combination Product (Y/N): N
• PMA/510(K) Number: K141121
• 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): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 705042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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