MAUDE Adverse Event Report: SYNTHES BETTLACH; BIT, DRILL

Catalog Number 315.400

Device Problems Break (1069); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the central supply sterile department discovered that the two drill bits in the antegrade femoral nail set looked different but had the same reference number.One of the drill bits was missing the sharp tip at the end hat makes placement on the bone during perfect circles easier.This was not a se of the tip breaking off.The threads on the drill were also different.No patient involved.No surgery.This report is 1 of 1 for (b)(4).

Event Description

Additional event clarification: the complained drill bit was missing the sharp tip at the end that makes placement on the bone [to drill] perfect circles easier.This is not a case of the tip breaking off the drill bit.The complained device is just different than expected but has the same reference number as the desired drill bit.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event: date unknown.Brand name reported is - drill bit ø4 l195/170 3flute.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record(s) 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: the subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: product investigation evaluation: the investigation of the returned drill bits (315.400) has shown that both are worn.It is clearly visible that the front part of one drill bit is indeed different than the other, but unfortunately we are not able to comment on that as we were not given sufficient information (different drill bit had been returned lot number is unknown).We can only address the condition on the returned drill bits, which are both clearly worn on the tip as well as on their cutting edges.Further investigation showed conformity of the articles in question to the company specification and no apparent fault of material or manufacturing was detected (manufactured in may / june 2008).We conclude that these damages were caused due to normal wear and tear over the years.No product fault could be detected.Neither a manufacturing nor design related failure could be detected; no further action required.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.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4484964
• MDR Text Key: 5345125
• Report Number: 9612488-2015-10103
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315.400
• Device Lot Number: 2361122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2015; 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2008
• Type of Device Usage: Unknown
• Patient Sequence Number: 1