MAUDE Adverse Event Report: STRYKER GMBH 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 4922-2-020

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The attachments could not be attached.Replacement devices were available.Additionally reported: the attachment could not be put into the 5-hole pin holder.The approaches did not fit into the "star bore" provided for them.The original h3 7mm t-wrenches to loosen the screws during testing were used.The customer noticed the problems already when connecting the pin holder with the attachments, so no further assembly was made.

Event Description

The attachments could not be attached.Replacement devices were available.Additionally reported: the attachment could not be put into the 5-hole pin holder.The approaches did not fit into the "star bore" provided for them.The original h3 7mm t-wrenches to loosen the screws during testing were used.The customer noticed the problems already when connecting the pin holder with the attachments, so no further assembly was made.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for valuation and matches the reported failure mode.The device inspection, regarding the 5 hole pin clamp showed that the clamp is severely damaged.The clamp's holes show clear evidence of wear.Moreover, a functional inspection was held.Indeed the posts cannot be assembled with the clamp due to the damages noticed in the clamp.The posts are fully functional despite having some signs of wear noticed along the part.The posts were able to be assembled with a non defective clamp.Therefore, the failure was caused by the mishandling of the clamp, the use of large forces damaged the part.This case is classified as a user related issue.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 any further information is provided, the complaint report will be updated.

• Brand Name: 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9721595
• MDR Text Key: 193388803
• Report Number: 0008031020-2020-00466
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540681010
• UDI-Public: 04546540681010
• Combination Product (y/n): N
• PMA/PMN Number: K111786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4922-2-020
• Device Catalogue Number: 49222020
• Device Lot Number: L36942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR