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

Model Number 53-27214S

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 03/21/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7383022
• MDR Text Key: 104043135
• Report Number: 0008031020-2018-00256
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540593870
• UDI-Public: (01)04546540593870
• Combination Product (y/n): N
• PMA/PMN Number: K080667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 53-27214S
• Device Catalogue Number: 53-27214S
• Device Lot Number: 1000234664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR