MAUDE Adverse Event Report: SYNTHES MONUMENT 10.0MM CANNULATED DRILL BIT LARGE QC/190MM; BIT, DRILL

Catalog Number 360.05

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).The patient¿s exact weight is unknown, but the patient is reportedly obese.Device is an instrument and is not implanted or explanted.(b)(4).Product investigation summary: the following complaint device(s) were received for evaluation: one (1) 2.5mm kirschner wire (k-wire) with trocar point 285mm (part: 292.26 / lot unknown).One (1) 10.0mm cannulated drill bit large quick coupling/190mm (part: 360.05 / lot number: u219211).The complaint condition for the drill bit was unable to be confirmed as the drill bit was able to be inserted over the k-wire with no interference.As the complaint was unable to be replicated, and no defects or deficiencies were identified with the returned instruments, no further investigation was necessary.Both instruments can be utilized in the depuy synthes titanium cannulated humeral nail system.The k-wire is used to aid in the insertion of the nail and to help guide the drill bit during opening of the medullary canal.Upon visual inspection it can be seen that one the distal tip is damaged due to coming into contact with the k-wire.The relevant drawing was reviewed.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.Device history record review: release to warehouse date: (b)(6) 2015.Packaged by: synthes: (b)(6).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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.

Event Description

It was originally reported that a 2.5mm kirschner wire broke into two (2) pieces during a midshaft humerus procedure on (b)(6) 2016.A portion of the broken wire remained inside the patient's intramedullary canal.The malfunction of the device, and the surgeon's attempt to retrieve the fragment, resulted in a ten (10) to twenty (20) minute surgical delay.The procedure was completed without further incident.The patient remained in good condition following the completion of the procedure.Update: it was further reported (on (b)(6) 2016) that the drill bit interfered with the k-wire after it was inserted into the bone causing it to break into two (2) pieces.The procedure was completed successfully.This report is 2 of 2 for (b)(4).

• Brand Name: 10.0MM CANNULATED DRILL BIT LARGE QC/190MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5470366
• MDR Text Key: 39356842
• Report Number: 1719045-2016-10176
• Device Sequence Number: 1
• Product Code: HTW
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 360.05
• Device Lot Number: U219211
• Other Device ID Number: (01)10886982197368(10)U219211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• 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
• Patient Age: 78 YR