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	09/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during drilling the bone for insertion of the device, when starting to place the implant and after having screwed almost half of it, without applying any kind of force device broke into two pieces within the patient.Half of the implant was removed.Surgeon decided to place two twinfix 3.5 laterals to the broken one.Delay was less than 30 minutes and no patient injuries were reported.
Additional Manufacturer Narrative
Device was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The distal portion of the anchor has broken at the suture slot and was not returned for examination.Dimensional assessment is prohibitive due to the anchors condition.With the limited clinical details regarding patient bone quality and site preparation a root cause cannot be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Complaint history search revealed no additional complaints for this production lot.

• 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: 6846217
• Report Number: 1219602-2017-01086
• Device Sequence Number: 16544190
• Product Code: MAI
• UDI-Device Identifier: 03596010539304
• UDI-Public: (01)03596010539304(17)180601(10)50552190
• 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: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 06/01/2018
• Device Model Number: 7210710
• Device Catalogue Number: 7210710
• Device Lot Number: 50552190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1