MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T7; PLATE, FIXATION, BONE

Catalog Number 62-27015

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is not available.

Event Description

Customer reported that the case was abandoned after the patient had been anesthetised because the appropriate tools were not available.The t7 blade did not fit into the anchorage screwdriver or other handles that were in the theatre.The blade was dropped and the surgeon no longer felt comfortable to continue the surgery without the correct screwdriver and the patient was sent back to the ward.Also, the screws present in surgery were cross head screws and not the t7 screws because the customer was misinformed of the products.The variax distal radius plate has been removed on the same day in afternoon upon second attempt.The reason for removal is unknown.

Event Description

Customer reported that the case was abandoned after the patient had been anesthetised because the appropriate tools were not available.The t7 blade did not fit into the anchorage screwdriver or other handles that were in the theatre.The blade was dropped and the surgeon no longer felt comfortable to continue the surgery without the correct screwdriver and the patient was sent back to the ward.Also, the screws present in surgery were cross head screws and not the t7 screws because the customer was misinformed of the products.The variax distal radius plate has been removed on the same day in afternoon upon second attempt.The reason for removal is unknown.

Manufacturer Narrative

The reported event that screwdriver blade, t7 was alleged of 'known misuse reported by the user' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.Based on the given information though, we do suppose that the surgeon encountered some difficulties (customer was misinformed of the products) and the appropriate screwdriver was not available.And the wrong t7 screwdriver 62-27015 was use instead of the correct 62-27007 cross-pin blade.A review of the device history was not possible because the lot number was not communicated.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.Labelling review: the operative technique was reviewed: ''system components ¿ instruments variax distal radius locking implant & recessed screw module* * recessed screw module to be used with self-retaining blades (62-27015 - t7 blade or 62-27007 ¿ cross-pin blade)'' [original statement(s)] the instruction for use (v15011 rev ab instrument ifu_ml) was reviewed: ''ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument; please remember that product systems may be subject to alterations that affect the compatibility of the instrument with other instruments or with implants! for your information, avail yourself of the training courses and publications offered by stryker (e.G.Operative techniques).[.] special comments for application ¿ only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.¿ always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.¿ the design of the instrument must not be modified in any way.¿ ensure that drilling and cutting tools are sharp.¿ before every operation, ensure that all devices to be used during the operation function correctly with each other.¿ in the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.¿ reusable instruments must be cleaned directly after usage.[.]'' [original statement(s)].

• Brand Name: SCREWDRIVER BLADE, T7
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8359257
• MDR Text Key: 137428703
• Report Number: 0008031020-2019-00087
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540594150
• UDI-Public: 04546540594150
• Combination Product (y/n): N
• PMA/PMN Number: K141430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 62-27015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other