MAUDE Adverse Event Report: SYNTHES SELZACH 10MM CANNULATED TAPERED DRILL BIT; TEMPLATE

Catalog Number 03.037.021

Device Problem Break (1069)

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional patient information: patient height reported as: (b)(6).Patient initials are (b)(6).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing site: (b)(4), supplier: (b)(4), manufacturing date: 02.May 2016.No ncrs were generated during production.Review of the device history record 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 three drill bits broke and there was difficulty drilling through a trochanteric fixation nail advanced (tfna) during an intramedullary (im) rodding of a left hip.After the nail and guide wire had been placed, as the surgeon used a stepped drill, the back end of a stepped drill bit snapped off.Then another identical stepped drill bit broke at the tip.Another set was opened and a tapered drill bit broke at the tip when it hit the nail, leaving fragments in the patient's hip.When the surgeon could not drill through the tfna and into the femoral head, that original nail was removed and replaced with a trochanteric fixation nail (tfn).There was a reported one hour surgical delay and additional x-rays were required.The procedure was then successfully completed with no harm to the patient.Concomitant devices reported: stepped drill (part #unknown, lot #unknown, quantity 1).This is report 1 of 3 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the following received subject devices by customer quality (cq): one 10mm/130 deg ti cann tfna 320mm/left ¿ sterile (part number: 04.037.053, lot number: h127743), one 10mm cannulated tapered drill bit (part number: 03.037.021, lot number: f-19306), one 6mm/9mm cannulated stepped drill bit (part number: 03.037.022, lot number: f-19278), one 6mm/9mm cannulated stepped drill bit (part number: 03.037.022, lot number: f-19282).The complaint condition is confirmed for all parts.A visual inspection and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The complaint devices are part of the depuy synthes tfnadvanced proximal femoral nailing system for intramedullary fixation of proximal femoral fractures.The nail (part number: 04.037.053, lot number: h127743) was returned with significant damage along the outside wall of the proximal locking hole and the inner wall of the distal locking hole.Slight abrasion along one of the grooves of the nail was also identified; misalignment has been determined to be the reason why the damage occurred.The tapered drill bit (part number: 03.037.021, lot number: f-19306) was returned with a portion of the distal tip broken off (approximately 1.81 mm is missing from the device) and was not returned.The stepped drill bit (part number: 03.037.022, lot number: f-19278) was returned with the proximal tip broken off (approximately 20.37mm had sheared off) and was not returned.The stepped drill bit (part number: 03.037.022, lot number: f-19282) was returned with the distal tip broken off (approximately 4.68mm had sheared off) and was not returned.Relevant drawings for the returned devices were reviewed: the design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined as the circumstances at the time of the event are unknown.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 10MM CANNULATED TAPERED DRILL BIT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5959727
• MDR Text Key: 55025693
• Report Number: 3000270450-2016-10225
• Device Sequence Number: 1
• Product Code: HWT
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.021
• Device Lot Number: F-19306
• Other Device ID Number: (01)10886982070371(10)F-19306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2016
• 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
• Treatment: STEPPED DRILL, PART# UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 72