MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ASSY, TITANIUM INTRALINE ANCHOR, 5.5MM; SCREW, FIXATION, BONE

Model Number	3910-400-050
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/31/2019
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 there was a revision surgery due to the sutures pulling out of the anchor post-op.
Event or Problem Description
It was reported that there was a revision surgery due to the sutures pulling out of the anchor post-op.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: sutures pulling out of the anchor 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 schlerotic bone that may thicken the cortical layer - non-compliant patient - anchor receives excessive force (i.E.Trauma) the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, ASSY, TITANIUM INTRALINE 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: 9596532
• Report Number: 0002936485-2020-00040
• Device Sequence Number: 18981378
• Product Code: HWC
• UDI-Device Identifier: 07613154890088
• UDI-Public: 07613154890088
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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 Model Number: 3910-400-050
• Device Catalogue Number: 3910-400-050
• Device Lot Number: 19074AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/10/2020
• 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
• Patient Age: 66 YR