MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-100-035
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: it is alleged that patient had unexplained pain.Probable root cause: design.-wrong raw material or manufacturing agent selected.-in-process cleaning not effective at removing manufacturing residuals.-not enough strict controls placed on raw material source and purity process.-contamination during process.-in-process cleaning not performed to spec.Application.-contamination of devices.
Event or Problem Description
It was reported that the patient needed revision surgery.However, please note that the metal in this device is highly unlikely to cause the alleged reaction.
Additional Manufacturer Narrative
Update awareness date to 12-jun-2018.
Event or Problem Description
It was reported that the patient needed revision surgery.However, please note that the metal in this device is highly unlikely to cause the alleged reaction.

• Brand Name: PKG., WEDGE HS SUTURE ANCHOR II, 5.0MM
• 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: 7665394
• Report Number: 0002936485-2018-00521
• Device Sequence Number: 1980162
• Product Code: MBI
• UDI-Device Identifier: 37613154015307
• UDI-Public: 37613154015307
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-100-035
• Device Lot Number: 10173AE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2014
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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: 75 YR
• Patient Weight: 79