MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PLLA/HA 5.5 W/3 UB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72202603
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter international zip code: (b)(6).
Event or Problem Description
It was reported anchor broke while inserting on humeral head.Broken anchor was removed from the patient.No procedure delay or patient injuries were reported.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.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.
Additional Manufacturer Narrative
Device was returned for evaluation.The device was used during a procedure while inserting into the humeral head.The handle and spring action are functional.The shaft is in relatively good condition and does not show major damage, although the forks have been bent.This indicates force was applied and loss of axial alignment.A two-finger ao technique should be used to insert the anchor.Per the ifu: breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.The associated ifu recommends: a 4.5 mm spade tip drill for a pilot hole and also a 5.5/6.5 threaded dilator for prep.No root cause related to the manufacturing of this device can be established.

• Brand Name: TWINFIX ULTRA PLLA/HA 5.5 W/3 UB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6841023
• Report Number: 1219602-2017-01076
• Device Sequence Number: 16521810
• Product Code: MAI
• UDI-Device Identifier: 03596010647597
• UDI-Public: (01)03596010647597(17)200910(10)50563795
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2017

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: 09/10/2020
• Device Model Number: 72202603
• Device Catalogue Number: 72202603
• Device Lot Number: 50563795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/11/2017; 10/18/2017
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 10/11/2017; 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1