MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 95MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	33625095
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that a standard lag screw omega 95mm length got bent during surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Since it was not communicated which of the two reported lag screws was the one which got bent, both have been investigated.Based on investigation, the root cause was attributed to be user related.Most likely, the lag screw was not properly assembled with the rest of the one-step assembly system and this caused disconnection during the insertion process, thus leading to screw deformation and consequent inability to slide the plate onto the lag screw.In this regard, our ifu state to ¿repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure¿.These are some of the other possible causes which might have contributed to the reported event: - the implant had already been used once.Single use devices cannot be reused, as they are not designed to perform as intended after the first usage.- the implant had not been carefully inspected prior to surgery to determine if it had been damaged during storage.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 a (b)(6) male, non-smoker, fit and well normally with no regular medications broke his hip from a bicycle collision at the velodrome.An intertrochanteric fracture was seen on radiographs and the patient was implanted with a 4 hole dhs.The surgeon also reported that of note his bone quality was excellent.The surgeon reported that on first attempt the lag screw base became bent and flange developed.And this prevented plate from sliding onto screw.A second surgeon scrubbed in to retrieve screw and new screw inserted.Sales rep is unable to specify which of the 2 screws was the bent one in each case, as theatre staff did not mark down which one was implanted and which one was not.The only instrument used in conjunction with the implant was the one step insertion instrument.No photo of the affected device is available.

• Brand Name: STANDARD LAG SCREW OMEGA 95MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6520542
• Report Number: 0008031020-2017-00263
• Device Sequence Number: 885467
• Product Code: KTT
• UDI-Device Identifier: 07613327093032
• UDI-Public: (01)07613327093032(17)210930(10)V35996
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K955306
• 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
• Report Date (Section B): 04/25/2017

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: 09/30/2021
• Device Catalogue Number: 33625095
• Device Lot Number: V35996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• 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: 57 YR