MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

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

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device was not implanted/explanted.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the devices broke during surgery.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Manufacturing investigation evaluation: the threaded shaft is completely broken off; the remaining portion measures approximately 2.4mm.The broken off, threaded shaft was not sent back for investigation.The microscopic investigation shows that the cruciform drive is moderately damaged.The tops of the cross slots have displaced metal in the clockwise and anti-clockwise direction relative to torque applied and presenting mechanical overload.The relevant dimensions at the fracture face of the screw were checked and found to be in compliance with the actual technical drawing and specifications.A final manufacturing conclusion cannot be presented because of product¿s condition and the unknown lot number.Visual investigation and comparing with the actual technical drawing indicates that the device met the specifications before the damage occurred.Based on the provided information, the exact cause of this occurrence cannot be determined.The appearance of the damage and fracture face indicates that a mechanical overloading situation (for example: exceptionally hard bone) caused the breakage of these screws.In this relation, the surgical technique mentions: in dense cortical bone, it may be necessary to predrill with a 1.5 mm drill bit.No manufacturing related issues were identified and/or confirmed.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5053531
• MDR Text Key: 24932874
• Report Number: 2520274-2015-15666
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1