MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR 2.9 WITH 2 ULTRABRAID; SCREW, FIXATION, BONE

Model Number	72200775
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder operation, area was prepared with 2.9 mm drill.First anchor was placed appropriately but second anchor tap was broken while it was being placed.Anchor was removed from patient and new anchor was placed by preparing new hole.No patient injuries were reported.
Additional Manufacturer Narrative
Device was returned for evaluation.The device was used for a shoulder instability and labral tears repair procedure.The shaft is slightly bowed.The anchor was returned damaged.It has collapsed at the thru eyelet.The threads and insertion area are damaged.This was the second of two anchors used.The first was successfully fixed.Bone quality was not indicated.Drill size was appropriate although it was not reported whether the customer used the specified drill bit for this particular anchor.It was commented that ¿the tap was broken while being placed¿.The physical condition of the device, anchor and the failure description is consistent with off axis insertion for the second anchor fixation attempt.No root cause associated with the manufacture of this device could be supported.Use error may have been a contributing factor to the event.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: BIORAPTOR 2.9 WITH 2 ULTRABRAID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6822178
• Report Number: 1219602-2017-01035
• Device Sequence Number: 18846978
• Product Code: HWC
• UDI-Device Identifier: 03596010585967
• UDI-Public: (01)03596010585967(17)180911(10)50565412
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 09/20/2017

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: Physician
• Device Model Number: 72200775
• Device Catalogue Number: 72200775
• Device Lot Number: 50565412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR