MAUDE Adverse Event Report: SYNTHES (USA); BIT,DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Sedation (2368); No Code Available (3191)

Event Date 05/10/2015

Event Type  Injury  

Event Description

It was reported that during a repair of an intertrochanteric hip fracture, a surgeon had difficulty inserting the first of two 11mm/130 degree titanium cannulated trochanteric fixation nails (170mm-sterile).Prior to inserting the first of three lag screws, the technician loaded a 95mm lag screw without issue.The resident inserted the 95mm lag screw into the patient but the lag screw was determined to be too short; therefore, the attending physician requested that the device be exchanged/replaced with a 100mm lag screw.The scrub technician then loaded the 100mm lag screw onto the t-handle inserter.During the insertion, the resident inserted the lag screw approximately halfway into the patient when there was a ¿clunking¿ sound and the handle appeared have potentially slipped.Unclear what had happened, the resident continued to insert the lag screw and positioned the t-handle parallel to the femur.Reportedly, the resident and the attending physician were not able to completely engage the locking mechanism of the lag screw because it appeared to have hit a hard stop.Under fluoroscopy, it was observed that the lag screw inserter was not properly aligned and it appeared that the t-handle lag screw junction had slipped.A second lag screw inserter retrieved and the surgeon exchanged it with the one with a bent tine.The surgeon then attempted to reposition the lag screw with the second inserter so that the handle was parallel to the femur.Despite making micro adjustments forward and backward 10 degrees, the lag screw locking mechanism appeared to continue to hit a hard stop.The surgeon made the decision to exchange the nail with a second 11mm/130 degree titanium cannulated trochanteric fixation nail (170mm-sterile).The resident attempted to re-drill the lateral cortex with an 11mm drill bit when the patient experienced and iatrogenic fracture.The resident later reported that he was taught by a different attending physician that he should press the drill bit firmly against the bone before drilling and was uncertain if this contributed to the fracture.Ultimately, the surgeon decided to convert to an 11mm/130 degree titanium cannulated trochanteric fixation nail (360mm-sterile) and due to the position of the lateral cortex he chose to insert a 110mm lag screw.Additionally, the femur fracture was reduced with a long trochanteric fixation nail but the patient status is currently unknown.The reported surgical delay was estimated to be between 45 to 60 minutes.This report is for one unknown 11mm drill bit.This report is 6 of 6 for (b)(4).

Manufacturer Narrative

Patient information was not provided by reporter.This report is for one unknown 11mm drill bit.Part and lot number were not reported.Device is an instrument and is not implanted/explanted.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Pma/510k: unknown, as specific part and lot numbers for the complainant drill bit were not provided.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.

Manufacturer Narrative

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

Additional information was reported that sales rep met with the hospital staff and confirmed that the complaint description was accurately captured.Sales rep further reported being confused as the wrong lag screw was returned.Rep added that all available devices were washed and returned and that the lag screw the surgical team had issues with during the surgery is not available for return/investigation.

• Type of Device: BIT,DRILL
• 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: 4820994
• MDR Text Key: 5903411
• Report Number: 2520274-2015-14222
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 06/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/25/2015; 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention