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

Catalog Number	3910-400-055
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the anchor is placed, but it makes a 1 cm crack in radius.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.
Event or Problem Description
It was reported that the anchor placement caused a crack in the bone.

• Brand Name: PKG, ASSY, TITANIUM INTRALINE ANCHOR, 5.5MM W/NEEDLES
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8700911
• Report Number: 0002936485-2019-00236
• Device Sequence Number: 16732957
• Product Code: HWC
• UDI-Device Identifier: 07613154890071
• UDI-Public: 07613154890071
• Combination Product (Y/N): N
• PMA/510(K) Number: K071157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 3910-400-055
• Device Lot Number: 18354AE2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/14/2019
• 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