MAUDE Adverse Event Report: SYNTHES HAGENDORF 1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 316.448

Device Problem Break (1069)

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

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional product codes: erl and hbe.Device is an instrument and is not implanted/explanted.(b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: march 21, 2007.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that two devices broke intra-operatively during a planned explant procedure.No broken parts were left in the patient.There was no delay to surgery time and no patient harm reported; the procedure was completed successfully.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

The investigation identified lot 3332424 for part 316.448.Udi with synthes lot: (01)(b)(4).Product investigation summary: the following two (2) drill bits have been received for investigation: part 316.453 / lot 3362743 and part 316.448 / #lot 3332424.The investigation will be merged, since the complaint against the parts is identical.The products were returned in a packaging different from the original packaging.The visual inspection of the returned drill bits has shown that approximately 7mm from the fluted tip sections are broken off.The broken portions were not received.Due to the damages, the complaint relevant dimensions could not be checked against print specifications.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The used material was stainless steel 1.4112 as required and the measured hardness was within the specifications of 600 0/+55 hv.The broken surfaces are homogenous, which indicates material conformity as well.Based on the provided information, the exact cause of this complaint cannot be determined.A possible reason for the damage could be a metallic contact or flute blockage via bone material.It is likely that this occurrence, in combination with a mechanical overload situation, has caused the breakage of the delicate 1mm drill bits.Please note: blunt drill bits require more mechanical power during application; therefore, it is important for the user to check the instruments for sound surfaces, correct adjustment, and proper function prior to use.Severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces should not be used.Based on the manufacturing investigation results, it can be concluded that the cause of failure is not due to any manufacturing non-conformances.No indication for product related issues was found.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

The updated information provided in the previous medwatch was based upon an incorrect lot number in the investigation.This number has been updated to reflect what was originally reported, as that lot number appeared on the returned device.The lot numbers of the returned devices were incorrectly provided in the investigation summary.Below are the updated lot numbers for the devices (which correspond to the originally reported lots from the complainant).Part 316.453 / #lot f-17027 / drill bit ø 1.0mm w/stop, l 44.5/8mm.Part 316.448 / #lot sx406924 / drill bit ø 1.0mm w/stop, l 44.5/8mm.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: 1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5815134
• MDR Text Key: 51019116
• Report Number: 3003875359-2016-10425
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 316.448
• Device Lot Number: SX406924
• Other Device ID Number: (01)07611819071407(10)SX406924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2007
• 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