MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; PIN, FIXATION, SMOOTH

Catalog Number UNK_ICO

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that during a surgical procedure, the k-wire broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6; the reported event, for pin/wire break, was not confirmed as the product was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device not available for return.

Event Description

It was reported that during a surgical procedure, the k-wire broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6; the reported event, for pin/wire breakage, was confirmed, a partial unknown piece of a pin/wire was returned for evaluation.As the pin/wire could not be identified and that only a partial piece of a pin/wire was returned further evaluation of this partial piece of pin/wire was not possible.As a result a cause for the pin/wire breakage could not be determined in this case.

Event Description

It was reported that during a surgical procedure, the k-wire broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10292182
• MDR Text Key: 199477389
• Report Number: 0001811755-2020-01736
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

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: UNK_ICO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 09/04/2020; 10/01/2020
• Supplement Dates FDA Received: 09/04/2020; 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1