MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD AHR XL 1 #2 UB STR BL-CB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72205061
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the drill guide bone was placed, the surgeon attempt to insert the drill down the guide and noticed resistance,the surgeon removed the guide to inspect and notice that the style tip of the suture fix curved anchor inserter had broken off inside the drill guide.A back- up device was used to completa the surgery.No patient injury reported.
Additional Manufacturer Narrative
The product was not returned for evaluation.Due to product unavailability, the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences unrelated to manufacture that could compromise product performance or integrity include: 1) incompatible force or torque or leverage applied.2) change of approach during use.3) device bent past intended flex conditions.4) recommended maintenance not performed.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
Only a small piece of the suturefix curved suture anchor inserter was returned for evaluation.Visual assessment of the piece confirmed its breakage.The distal shaft of the curved suturefix anchor inserter has broken off inside the drill guide.The condition of the device indicates excessive force was placed on the guide during use resulting in the observed damage and breakage of the suturefix inserter.

• Brand Name: SUTUREFIX CRVD AHR XL 1 #2 UB STR BL-CB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7927237
• Report Number: 1219602-2018-01363
• Device Sequence Number: 1797515
• Product Code: MBI
• UDI-Device Identifier: 00885556686294
• UDI-Public: (01)00885556686294(17)210305(10)50718648
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2019

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 Expiration Date: 03/05/2021
• Device Model Number: 72205061
• Device Catalogue Number: 72205061
• Device Lot Number: 50718648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 02/14/2019
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/05/2018; 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1