MAUDE Adverse Event Report: SYNTHES USA; SCREW FIXATION INTRAOSSEOUS

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Potential part numbers of 201.928 or 201.932 provided; it is unknown which is the complained device.Device broke during insertion; device not considered implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device history records review could not be completed.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 that the screw broke off while it was being tightened during a mandibular condyle fracture procedure.Part of the screw was left inside the patient because was not possible to remove it.This report is for an unknown screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: one (1) unknown screw was received with a break at the threaded shaft.The broken part was not available for evaluation.The microscopic view of the broken portion shows a homogenous surface, which indicates material conformity.As per report, the part number is not confirmed.However, the likely product codes are 201.928 or 201.932.As such, the manufacturer can only declare that, for article 201.928 or 201.932, the raw material corresponds with that required by specifications and international standards.The manufacturing review could not be performed as the article and lot number of the screw is unknown.Based on the provided information, and without all involved parts, it is impossible to determine the cause of this occurrence.As such, no final conclusions were possible.However, it is most likely that a mechanical overload caused this breakage during the insertion step.No product fault could be detected.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.

• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5701452
• MDR Text Key: 46646477
• Report Number: 2520274-2016-13023
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention