MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-312
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
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 inserter tip broke and remained in the patient.
Event or Problem Description
It was reported that the inserter tip broke and remained in the patient.
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: inserter tip broken probable root cause: design -inserter/implant not compatible with guide.-inserter material/design too weak.-inserter shaft cannot bend around curved guide.-drill not designed to center hole with respect to guide.-guide mouth not designed to grip bone.-guide not able to be gripped tightly.Process -inserter, implant, and/or guide manufactured out of spec.-anchor coating process out of specification.Application -excessive force impacting inserter.-movement of guide out of orientation to pilot hole.-use of wrong drill.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT
• 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: 11737212
• Report Number: 0002936485-2021-00229
• Device Sequence Number: 3591346
• Product Code: MBI
• UDI-Device Identifier: 37613327176927
• UDI-Public: 37613327176927
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K170098
• 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): 06/08/2021

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: 3910-500-312
• Device Lot Number: 20347AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: 17 YR