MAUDE Adverse Event Report: S.B.M. SAS COMPOSITCP RESORBABLE INTERFERENCE SCREW; BONE FIXATION SCREW

Catalog Number 110004612

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product is not available for evaluation because 1/2 screw is implanted and 1/2 screw is scrapped.There is no injury to patient - surgical delay: 10 mn.No other complaint concerning this batch number.But, because only half screw is stayed implanted, the fixation could be potentially compromised.We asked for more information.

Event Description

It was reported that : "acl tibial screw broke in half upon implantation.Half stayed implanted for fixation and half was scrapped.Doc was using a btb allograft that had been sized to a 10mm tunnel.System used was precision acl".It's stipulated that presence of a hard borne is a contributing factor to the event.

Manufacturer Narrative

Product is not available for evaluation because 1/2 screw is implanted and 1/2 screw is scrapped.There is no injury to patient: surgical delay: 10 mn.No other complaint concerning this batch number.But, because only half screw is stayed implanted, the fixation could be potentially compromised.We asked for more information.Follow-up 1 / final report: questions to complete our investigation: half screw stayed implanted, is the fixation compromised or potentially compromised? it is not likely to cause or not contribute to serious injury? not any clinics consequences for the patient? did doctor allege deficiency in the performance of the device? no responses.Conclusion of expertise report concerning manufacturing data (half of broken screw was not available for analysis): this batch of screws presents no manufacturing defects.Everything complies with specifications.We note the hypothesis that hard bone was a factor which contribute to the event.This file is closed.

Event Description

It was reported that : "acl tibial screw broke in half upon implantation.Half stayed implanted for fixation and half was scrapped.Doc was using a btb allograft that had been sized to a 10mm tunnel.System used was precision acl".It's stipulated that presence of a hard borne is a contributing factor to the event.

• Brand Name: COMPOSITCP RESORBABLE INTERFERENCE SCREW
• Type of Device: BONE FIXATION SCREW
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 7556658
• MDR Text Key: 109912274
• Report Number: 3004549189-2018-00001
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K090994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Catalogue Number: 110004612
• Device Lot Number: 153401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR