MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932E

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).The tip of the screw remains embedded, therefore device not considered explanted.Date returned to manufacturer.Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.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

It was reported that on (b)(6) 2018, patient underwent an open reduction internal fixation (orif) of the mandible.During the procedure, the intermaxillary fixation (imf) screw self-drilling broke.Upon the screw breaking, the surgeon abandon the broken screw tip and put in a screw next to the broken piece.The surgeon did not try to remove the broken part from the bone.The procedure was successfully completed with a surgical delay of 10-15 seconds.No adverse event and patient harm reported.This report is for one (1) 2.0mm imf screw 12mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Corrected.Due to screw breakage, it could not be implanted as planned.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A product development investigation was performed for the subject device: it was reported that on june 04, 2018, patient underwent an open reduction internal fixation (orif) of the mandible.During the procedure, the intermaxillary fixation (imf) screw self-drilling broke.Upon the screw breaking, the surgeon abandon the broken screw tip and put in a screw next to the broken piece.The surgeon did not try to remove the broken part from the bone.The procedure was successfully completed with a surgical delay of 10-15 seconds.No adverse event and patient harm reported.The instrument was received with the reported condition of ¿broken (2+ pieces) intraoperatively : rm & functional embedded device : nrm¿ the following investigation flow was performed: broken: visual inspection performed at customer quality (cq) confirmed the condition of breakage, which agrees with the reported complaint condition.The returned screw has broken at the self-drilling tip with the broken off tip fragment not returned (approximately 6.17 mm to 6.67 mm, per 201-928, calipers ca215p).The material surface at the fracture site appears homogeneous when viewed under 5x magnification at cq.Visual examination under 5x magnification also showed post manufacturing damage to the drive recess/cross slot.The damage suggests excessive force during attempted screw insertion the complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection was performed as below: drawings: 201_928 feature specifications per drawings: major thread diameter; ø2.0mm +/-0.1mm calipers (ca215p): ø 2.01 mm the measured dimension was found to be within the given specifications per the drawings referenced above.A review of the device history records was unable to be performed since the lot number was unknown.Tabulated product drawing 201_928 for the family of self-drilling, 3 flute ø2.0mm intramaxillary fixation (imf) screws were reviewed during this investigation.Proper use and maintenance for the device are addressed in the technique guide for the imf screw set (dsus/cmf/0814/0163(1)).The following warning exists on page 6, "warning: although the screws contain a self-drilling tip, it may be necessary to first pre-drill in dense cortical bone".The device is manufactured from 316l stainless steel which is an implant grade material and no issues were identified during the review.A definitive root cause for the breakage was unable to be determined.However, the post manufacturing damage on the cross slot suggests that a mechanical overload situation has led to the breakage.Additionally, there is no mention of pre-drilling activity in the complaint description and the following warning does exist in the technique guide "although the screws contain a self-drilling tip, it may be necessary to first pre-drill in dense cortical bone".A material check was not performed at cq because there is no indication that the material contributed to this complaint.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7639757
• MDR Text Key: 112410219
• Report Number: 2939274-2018-52644
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 06/19/2018
• Date Manufacturer Received: 07/27/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention