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	04/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was broken giving the third round.In order to remove the proximal part of the screw, a kelly clamp was used.We used a shaver in order to remove the rest of fragments.There was no significant delay or patient injury reported.A biorci 8x25 was used to finish theprocedure.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One unopened 7x25mm biorci screw (w/8mm head) was returned for evaluation.The screw in question was not returned.Dimensional assessment of the returned screw confirmed it met print specifications.Without the return of the device in question and the limited clinical details provided we are unable to determine a root cause for the reported breakage.

• 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: 7436993
• Report Number: 1219602-2018-00444
• Device Sequence Number: 13717030
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: (01)03596010426208(17)211019(10)50626552
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: 10/19/2021
• Device Model Number: 7207557
• Device Catalogue Number: 7207557
• Device Lot Number: 50626552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 06/14/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/22/2018; 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR