MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0277096275

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a surgical procedure, the blade broke in half.It was also reported that the patient received a small cut to skin approximately 1.5 cms long as result of this event and the blade fragment was successfully retrieved from the femoral head.It was further reported that there was a short surgical delay while the surgeon opened a new blade.It was also reported that the cut was glued at the end of the case when the surgeon was closing the patient.

Manufacturer Narrative

The blade involved with this event was returned for evaluation and the reported failure of breakage was confirmed.Investigation results indicate that the failure was replicated using a test blade of the same catalog and lot number, while cutting in white renshape.It was concluded that the breakage was due to the application of excessive force, bending and prying.The ifu's for handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity".

Event Description

It was reported that during a surgical procedure, the blade broke in half.It was also reported that the patient received a small cut to skin approximately 1.5cms long as result of this event and the blade fragment was successfully retrieved from the femoral head.It was further reported that there was a short surgical delay while the surgeon opened a new blade.It was also reported that the cut was glued at the end of the case when the surgeon was closing the patient.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM)
• 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: 6436076
• MDR Text Key: 70921153
• Report Number: 0001811755-2017-00793
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 4546540051769
• UDI-Public: (01)4546540051769(17)210112(10)16351027
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 0277096275
• Device Lot Number: 16351027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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
• Patient Outcome(s): Other