MAUDE Adverse Event Report: SYNTHES MONUMENT 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM REAMER

Catalog Number 357.403

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis. Patient weight is not available for reporting. Device is an instrument and is not implanted/explanted. The subject device has been received and is currently in the evaluation process. The results are pending completion and will be submitted in a supplemental report. A device history record review was performed for the subject device lot number, ur83273. Manufacturer: (b)(4). Date of manufacture (release to warehouse date): dec 14, 2007. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 during a trochanteric fixation nail (tfn) procedure to treat a right hip fracture on (b)(6) 2016, the drill bit broke. The guide wire had been inserted in the patient, the nail was down and the surgeon started to ream when the drill bit broke. Reportedly 10-15mm of the tip of the drill bit broke off and shattered into fragments. The surgeon opted to leave the fragments in the patient, as the fragments were lodged too far in the femoral head. There was approximately a one (1) minute surgical delay due to the reported event. Routine intraoperative x-rays were taken as standard for the procedure. The surgeon was satisfied with the stability of the construct. The procedure was completed successfully. The patient's postoperative status was reportedly good. Concomitant device reported: connecting screw (part # 357. 397, lot # unknown, quantity of 1); trochanteric fixation nail (part # unknown, lot # unknown, quantity of 1); guide wire (part # unknown, lot # unknown, quantity of 1). This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis. A product development investigation was performed for the stepped drill bit/cannulated (part number 357. 403, lot number ur83273). The subject device was returned with the complaint condition stating the most distal step of the returned drill bit was entirely sheared off at a slight angle. The broken portion was not received. The complaint condition is confirmed. A device history record (dhr) review, visual inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition. The device was determined to have been supplied by (b)(4) and released to the warehouse on 14-dec-2007. (b)(4) were generated for lot number on label not matching lot number on paperwork. These mrrs are not relevant to the complaint condition because an incorrect label has no relationship with a drill bit breaking. New labels were printed at the supplier with the correct lot #, re-bagged, re-labelled, inspected packaging and shipped back to synthes. Review of the device history record(s) showed there were no issues during the manufacture of this product that would contribute to this complaint condition. Visual inspection revealed that the most distal step of the returned drill bit was entirely sheared off at a slight angle. The broken portion was not received. The balance of the returned device was observed to be in fairly worn condition with markings and other signs of wear along its length. Dents and scraping were noted on the cutting edges near the fracture. A dent was also observed on the proximal edge. Replication of the complaint condition is not applicable as the device is already broken. A review of the current design drawing was performed. The design history was found to not impact the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The complaint condition is the result of force beyond the yield strength of the device. The forces encountered during use can be impacted by various factors such as use of bent / broken / damaged / worn instrument, technique, or dense bone. Thus, a definitive root cause of the circumstances leading to the breakage could not be determined. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6069328
• MDR Text Key: 58844447
• Report Number: 1719045-2016-10800
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/01/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 357.403
• Device LOT Number: UR83273
• OTHER Device ID Number: (01)10886982196262(10)UR83273
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 12/14/2007
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 11/01/2016 Patient Sequence Number: 1

Treatment

357.397, LOT UNKNOWN, QTY 1, CONNECTING SCREW; UNKNOWN GUIDE WIRE; UNKNOWN TROCHANTERIC FIXATION NAIL