MAUDE Adverse Event Report: STRYKER GMBH EMERGENCY BLADE FOR CAN. COMPR. SCREWS REMOVAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	07-40221
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the following issue: "the patient had an uncomplicated scaphoid non union.At exploration the fracture was visible but stable.It just required a compression screw across the fracture.The case proceeded with no problems and i inserted the guide-wire into the optimal position.The scaphoid was drilled - and ¿tapped¿ (he is young and fit and so the bone was likely to be of robust quality).On inserting the screw, shortly before it reached its optimal position, the top suddenly ¿stripped¿.It was then impossible to advance or to remove the screw and so it had to be left in a suboptimal position, without compression and not fully across the fracture site.I then closely inspected the end of the screwdriver, with magnification.It could clearly be seen that the hexagonal edges were worn and rounded off, which was entirely the cause of the problem." update: "the screw removal tool does not fit into the head of the screw - it is too big.It has never fitted.The tool cannot be used.It is the same for every kit.The screw could not be advanced nor withdrawn.¿.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported the following issue: "the patient had an uncomplicated scaphoid non union.At exploration the fracture was visible but stable.It just required a compression screw across the fracture.The case proceeded with no problems and i inserted the guide-wire into the optimal position.The scaphoid was drilled - and ¿tapped¿ (he is young and fit and so the bone was likely to be of robust quality).On inserting the screw, shortly before it reached its optimal position, the top suddenly ¿stripped¿.It was then impossible to advance or to remove the screw and so it had to be left in a suboptimal position, without compression and not fully across the fracture site.I then closely inspected the end of the screwdriver, with magnification.It could clearly be seen that the hexagonal edges were worn and rounded off, which was entirely the cause of the problem." update: "the screw removal tool does not fit into the head of the screw - it is too big.It has never fitted.The tool cannot be used.It is the same for every kit.The screw could not be advanced nor withdrawn.¿.
Additional Manufacturer Narrative
Please note corrections to d9/h3 as the device was not returned for evaluation.Please also note the correction to g1 manufacturing site.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The complaint was forwarded to r&d for review and following feedback was received: "the screw extractor with catalog# 07-40221 is designed to remove a damaged hexagon socket of a screw from the twinfix system, see also the detailed description of the screw extractor on page 12 of the instruction for use from the twinfix system instruments.Stryker has no alternative instrument in its portfolio that could be used for the extraction of such a small screw.If the screw extractor cannot be used for any reason an alternative instrument from a competitor can be used to remove the screw." 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: EMERGENCY BLADE FOR CAN. COMPR. SCREWS REMOVAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15237648
• Report Number: 0008031020-2022-00393
• Device Sequence Number: 6456318
• Product Code: LXH
• UDI-Device Identifier: 04546540388100
• UDI-Public: 04546540388100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/05/2022

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 Model Number: 07-40221
• Device Catalogue Number: 07-40221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male