MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number UNK_ICO

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Blade not returned to manufacturer for evaluation.

Event Description

It was reported that during a surgical procedure, the blade broke.It was also reported that an x-ray was completed and there was a two hour delay as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The blade subject to this event was not returned for evaluation, however, the associated handpiece (6208000000 sn (b)(4) was returned.Investigation results indicate that issues with the handpiece contributed to the reported event for blade breakage.The drive link was loose on blade mount base and eccentric bearing worn failures were identified.

Event Description

It was reported that during a surgical procedure, the blade broke.It was also reported that an x-ray was completed and there was a two hour delay as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6387358
• MDR Text Key: 69360891
• Report Number: 0001811755-2017-00724
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6208000000 SN (B)(4)
• Patient Outcome(s): Other