MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG,, ASSY., PEEK SOFT EYELET RC ANCHOR, 5.5MM; SCREW, FIXATION, BONE

Model Number	3910-400-010
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: broken.Probable root cause: design anchor not compatible with prepared hole size (peek only), anchor thread design makes insertion too difficult, inserter/anchor material/design too weak, anchor tip geometry not sharp enough for application, process: inserter, implant, manufactured out of specification.Application: excessive force torquing anchor or lateral force applied during insertion, not enough axial force during insertion, use of wrong tap improperly prepared hole (peek only), bone to hard for anchor insertion, bone not hard enough to maintain screw purchase, no pilot hole prepared (peek only).The failure mode will be monitored for future reoccurrence h3 other text : 81.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.

• Brand Name: PKG,, ASSY., PEEK SOFT EYELET RC ANCHOR, 5.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10477804
• Report Number: 0002936485-2020-00356
• Device Sequence Number: 3216185
• Product Code: HWC
• UDI-Device Identifier: 07613154644568
• UDI-Public: 07613154644568
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3910-400-010
• Device Catalogue Number: 3910-400-010
• Device Lot Number: 19044AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR