MAUDE Adverse Event Report: SYNTHES MONUMENT 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED

Catalog Number 310.510

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hsz.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ dhr review was performed for: part number: 310.520.Synthes lot number: u196082.Review location: (b)(4).Manufacture dates: 05/09/14.Orchid unique dhr revealed purchase orders of (b)(4) parts released for lot u196082 on 05/09/14.The review of the dhr showed that there was one nc for a package found partially torn which was scrapped.There were no other issues or nonconformances during the manufacture of the product that would contribute to this 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.

Event Description

Device report from synthes eu reports an event in (b)(6) as follows: during a surgery two (2) drill bits snapped off after seconds of drilling, there was a third drill bit available which worked well.There is currently no additional information.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product investigation summary: the investigation of the complainant drill bits has shown that both tips are broken off and both shafts are strongly untwisted.It is obvious that the drill bit was overturned with excessively applied torsional force.A visible sign on the tip indicates that the drill bit became stuck either in the bone or in the drill sleeve.Then, as the user turned with high force, the drill bits suffered damaged.It is recommended that the user not turn the drill bit during insertion into the drill sleeve in order to prevent jamming.These drill bits are very delicate and require extra caution during use.Please note; blunt drill bits require more mechanical power during the application; therefore, it is recommended that blunt or damaged instruments be exchanged prior to surgery.The review of the device history record showed that there was no issue during the manufacturing of the products that would contribute to this complaint condition.As no product fault could be detected, no further action is required.Device history record review: release to warehouse date: may 29, 2015 - manufacturing site: (b)(4).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.

• Brand Name: 1.8MM DRILL BIT/QC/100MM
• Type of Device: DRILL, BONE, POWERED
• 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: 5315590
• MDR Text Key: 34767287
• Report Number: 1719045-2015-10839
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.510
• Device Lot Number: U228109
• Other Device ID Number: (01)07611819018808(10)U228109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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