MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.5MM PEEK ZIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 3910-200-035

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Alleged failure: anchor fractured.Probable root cause: design.-anchor features (pitch, length, threads, material) does not promote adequate fixation.-instrumentation not designed to insert anchor to proper depth.-eyelet design causes suture to fray.Process: -anchor not manufactured to specification.-instrumentation manufactured out of specification.Application: -insufficient force used to tension repair (knots not tight enough).-too much bone removed/decorticated.-insufficient quality or quantity of bone that would compromise secure anchor fixation.-pathology such as sclerotic bone that may thicken the cortical layer.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported the anchor fractured during procedure.

• Brand Name: 5.5MM PEEK ZIP
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7452692
• MDR Text Key: 106246921
• Report Number: 0002936485-2018-00358
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-200-035
• Device Lot Number: 17293AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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
• Patient Age: 58