MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T7, 2.7X14MM; PLATE, FIXATION, BONE

Model Number	53-27214S
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device was misplaced by the customer.
Event or Problem Description
The surgeon reported that when implanting a distal radius plate, two 2.7mm screws were twisting in the hole and not getting purchase.The case was completed using 2 new 2.3mm screws and by drilling 2 new holes along the oblong.The patient was young and with good bone.There was a short delay of a few minutes while additional holes were drilled and new screws were obtained.The surgeon was satisfied with the outcome of the case.
Additional Manufacturer Narrative
The reported event that bone screw, t7, 2.7x14mm was alleged of 'device stripped/twisted' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The surgeon reported that when implanting a distal radius plate, two 2.7mm screws were twisting in the hole and not getting purchase.The case was completed using 2 new 2.3mm screws and by drilling 2 new holes along the oblong.The patient was young and with good bone.There was a short delay of a few minutes while additional holes were drilled and new screws were obtained.The surgeon was satisfied with the outcome of the case.

• Brand Name: BONE SCREW, T7, 2.7X14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7383027
• Report Number: 0008031020-2018-00255
• Device Sequence Number: 19084427
• Product Code: HRS
• UDI-Device Identifier: 04546540593870
• UDI-Public: (01)04546540593870
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K080667
• 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): 07/27/2018

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: 11/21/2021
• Device Model Number: 53-27214S
• Device Catalogue Number: 53-27214S
• Device Lot Number: 1000282521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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
• Patient Age: 30 YR