MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 5.0AB STR ANCHR W/2STR &NDLS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7210710
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the implant was broken for no reason.There was a surgical delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
One 5.0 twinfix ab suture anchor was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The distal portion of the anchor has broken and was not returned.The break is angular in nature.Dimensional assessment of the anchor is prohibitive due to its returned condition.A review of the clinical details was performed which confirmed a 6.0mm drill was used to prepare the insertion site.Per the devices ifu under warnings "breakage of the suture anchor can occur if insertion sites are not prepared with threaded dilator prior to implantation".
Event or Problem Description
It was reported that during the procedure the implant was broken for no reason.The pieces were removed from patient.There was a surgical delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries.

• Brand Name: TWINFIX 5.0AB STR ANCHR W/2STR &NDLS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7820173
• Report Number: 1219602-2018-01114
• Device Sequence Number: 16441202
• Product Code: MAI
• UDI-Device Identifier: 03596010539304
• UDI-Public: (01)03596010539304(17)201108(10)50695879
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151105
• 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
• Report Date (Section B): 10/12/2018

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: 11/08/2020
• Device Model Number: 7210710
• Device Catalogue Number: 7210710
• Device Lot Number: 50695879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1