MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM; SCREW, FIXATION, BONE

Catalog Number	325044S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
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 : "during an operation on the maleole, when the screw was screwed in, it broke.The patient had no clinical consequences, another screw was used instead but the duration of the procedure was extended".
Additional Manufacturer Narrative
The reported event that cannulated screw, partially threaded asnis iii ø4.0x50mm tl17mm was alleged of s-11 (breakage during surgery) could be confirmed.Since the device was returned for evaluation and meets the alleged failure mode.The device inspection revealed the following: the shaft of the returned screw is twisted, bent and broken indicating application of too much torsional force during screw insertion.The chances of surgeon encountering hard bone cannot be ruled out.Also, we did not receive any information if pre drilling and pre tapping may had been performed or not which is advised in case of hard bone.As per labeling review, a contact of an asnis iii screw with dense bone in a tangential direction may cause a deviation of the screw and/or a bending of the k-wire, which may result in damage to the implant.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by too high torsional force applied during screw insertion.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The hospital reported the following event : "during an operation on the maleole, when the screw was screwed in, it broke.The patient had no clinical consequences, another screw was used instead but the duration of the procedure was extended".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X44MM TL15MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8269494
• Report Number: 0008031020-2019-00044
• Device Sequence Number: 2081178
• Product Code: HWC
• UDI-Device Identifier: 07613327076165
• UDI-Public: 07613327076165
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 325044S
• Device Lot Number: L35821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/13/2019
• 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