MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207557
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a reconstruction of anterior cruciate ligament, at the end of the procedure, just at the moment of fixing the graft in the femoral tunnel, an interference screw (biorci 7 * 25, 8 mm head) was used.This was being screwed properly, but at the end of the process, the screwdriver was rolled inside the head's screw, and this did not advance more from that site.Surgeon tried to return it but this was not possible, screwdriver was removed, and it was noticed that the screw was broken and that it was not possible to move it forward or back.Due to this, the remaining screw head had to be broken to remove the fragment.No patient injury was reported.
Additional Manufacturer Narrative
One 7x25mm biorci screw w/8mm head was returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 12mm of the distal threads have broken off and were not returned for examination.The head of the screw was returned which is cracked.The break area is angular in nature.The condition of the screw indicates it was subjected to excessive force during insertion likely due to inadequate site preparation.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned, however a photograph was provided.The photo shows the head of a biorci screw that has broken off.Examination of the photograph is inconclusive.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7820172
• Report Number: 1219602-2018-01126
• Device Sequence Number: 2446925
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: (01)03596010426208(17)200720(10)50558219
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• 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): 10/10/2018

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: 07/20/2020
• Device Model Number: 7207557
• Device Catalogue Number: 7207557
• Device Lot Number: 50558219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/19/2018; 10/09/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/20/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR