MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 3.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375534000

Device Problems Component Falling (1105); Peeled/Delaminated (1454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that a suspected shaver fragment was left in the patient body.Recently discovered by (b)(6).Customer has the specimen and need us to check if it is from stryker shaver.Additional information: customer is further suspecting on the rf probe used, black coating was found falling off.There are 3 cases have done on this patient.First & second case is in 2012 & 2013 for knee arthroscopy in the same hospital (used 375-534-000, 375-544-000 & 279-351-100 only, the material of others instrument is stainless steel), the third case is in 2015 in another hospital, surgeon found below fragment when they open the joint.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: material/design error, manufacturing/assembly error (inadequate cleaning during manufacture), severe shipping conditions, corrosion of handpiece over time.And with reprocessing.

Event Description

It was reported that a suspected shaver fragment was left in the patient body.Recently discovered by revisit surgery in (b)(6).Customer has the specimen and need us to check if it is from stryker shaver.Additional information: customer is further suspecting on the rf probe used, black coating was found falling off.There are 3 cases have done on this patient.First & second case is in 2012 & 2013 for knee arthroscopy in the same hospital (used 375-534-000, 375-544-000 & 279-351-100 only, the material of others instrument is stainless steel), the third case is in 2015 in another hospital, surgeon found below fragment when they open the joint.

• Brand Name: 3.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4932801
• MDR Text Key: 22655276
• Report Number: 0002936485-2015-00656
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375534000
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• 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