MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD BLUNT OBT XL LNGTH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72205064
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 surgeon placed the drill guide on the bone, he attempted to insert the drill down the guide and noticed resistance.Surgeon removed the guide and inspect it noticing the flexible/jigsaw style tip of the first suture fix curved anchor inserter had broken off inside the drill guide.He attempted to push the part out the distal tip to free the drill guide, by inserting the obturator but this did not help.A backup device was available to complete the procedure with no significant delay or patient injuries reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One xl suturefix curved blunt obturator was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The distal tip is bent and twisted.The condition of the device indicates it was subjected to excessive force.Clinical details were provided stating that this device was used to attempt to clear an obstruction from a drill guide.

• Brand Name: SUTUREFIX CRVD BLUNT OBT XL LNGTH
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7961532
• Report Number: 1219602-2018-01396
• Device Sequence Number: 1681682
• Product Code: MBI
• UDI-Device Identifier: 00885556689189
• UDI-Public: (01)00885556689189(10)50703021
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

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 Model Number: 72205064
• Device Catalogue Number: 72205064
• Device Lot Number: 50703021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 01/29/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/06/2018; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1