MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.932E

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device broke intra-operatively and was not implanted / explanted.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.X.

Event Description

It was reported that during an intermandibular fixation, a quantity of two (2) 2.0 mm inter-medullary fixation (imf) screws, broke during insertion.The two (2) screw heads were easily retrieved.The tip of both screws remained retained in the patient's bone.There was a one (1) minute surgical delay.No further patient harm was reported.The surgery was completed successfully.No additional information was available.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product investigation summary: two (2) 2.0mm imf screws (reported as part 201.932e / lots unknown) were received for investigation.The tips/shafts of both screws were broken off and the broken portions were not returned.The remainder of the screws are in good condition with no other observable damages.It is unknown what caused the complaint condition, but it is possible that the screws were being inserted into dense cortical bone without first pre-drilling.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The exact part numbers for the devices was unable to be determined by visual inspection alone.However, the parts were reported to be 201.932e.Both implants are from the part family for 2.0mm imf screws (part 201.9xx).The relevant drawings were reviewed with no issues or discrepancies noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.Proper use and maintenance for the device(s) are addressed in the technique guide for the imf screw set.It is recommended that the surgeon pre-drill the hole for the imf screws when inserting into dense cortical bone.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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 12MM
• 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: 5492860
• MDR Text Key: 40085352
• Report Number: 2520274-2016-11591
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• 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