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

Catalog Number	3910-200-035
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip broke and potentially remained in the patient's joint space.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: break.Design -anchor not compatible with prepared hole size -drill design does not match anchor - anchor thread design makes insertion too difficult -inserter material/design too weak -inserter tip geometry not sharp enough for application process -inserter, implant, or drill manufactured out of specification.Application: -excessive force torquing anchor or lateral force applied during insertion -not enough axial force during insertion -use of wrong drill - improperly prepared hole -bone to hard for anchor insertion -bone not hard enough to maintain screw purchase -no pilot hole prepared - drill not inserted to proper depth.
Event or Problem Description
It was reported that the tip broke and potentially remained in the patient's joint space.

• Brand Name: 5.5MM PEEK ZIP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8413457
• Report Number: 0002936485-2019-00096
• Device Sequence Number: 2227372
• Product Code: MBI
• UDI-Device Identifier: 37613154644538
• UDI-Public: 37613154644538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-200-035
• Device Lot Number: 18045AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other