MAUDE Adverse Event Report: S.B.M. SAS SELF-LOCKING SCREW OTIS-LENGTH 55 MM; METALLIC BONE FIXATION SCREW

Catalog Number EVO9066055

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

For regularization - retrospective review / fda request.In the absence of a batch number, it is impossible to investigate the products.Hypothesis: the breakage may have occurred in torsion when loosening the screw (if the healing of the bone filled the self-tapping portion of the screws, it could make loosening very difficult).This type of incident remains very isolated.

Event Description

Fnc (b)(4) - for regularization - retrospective review / fda request.Recovery of 2 broken screw heads returned by the clinic.It is stipulated on the packaging: "explanted on (b)(6) 2015".No product code, no batch number - no message.

• Brand Name: SELF-LOCKING SCREW OTIS-LENGTH 55 MM
• Type of Device: METALLIC BONE FIXATION SCREW
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer Contact: regine bareilles ; zi du monge; lourdes, france 65100 ; FR 65100
• MDR Report Key: 8639439
• MDR Text Key: 146359338
• Report Number: 3004549189-2019-00085
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO9066055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other