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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH AWL Ø16.5/3.2 CANN

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SYNTHES BETTLACH AWL Ø16.5/3.2 CANN Back to Search Results
Catalog Number 03.010.365
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/16/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient information is not available for reporting. Implant and explant dates: device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. Initial reporting facility phone number is (b)(6). Pma 510(k): device is not distributed in the united states, but is similar to device marketed in the usa. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) reported an event in (b)(\6) as follows: it was reported that during an intramedullary nailing procedure on (b)(6) 2016, the awl was used to mark the entry point on the greater trochanter for the nail implant and broke during use. The awl left fragments in the patient's bone which took a "long" time to retrieve; however, the length of surgical delay was not specified by the reporter. This report is 1 of 1 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.
 
Event Description
It was reported there was a thirty (30) minute surgical delay due to the reported event. The surgeon had to drill the greater trochanter with 2mm drill bits in order to retrieve the awl pieces. No broken pieces were left in the patient. The procedure was successfully completed.
 
Manufacturer Narrative
Added ¿adverse event¿ and ¿required intervention¿ based upon the updated information received on may 18, 2016. Manufacturing investigation evaluation: the broken product was returned in a packaging different from the original packaging. The laser etching was readable, but there were usage marks visible and areas of bending. A device history record review was performed for the affected lot with no abnormalities or deviations detected, which could lead to the complaint failure. The dimension ø9-h7 (position 1 and 2) could not be measured due to the surface of the device having scratches and tears. In addition, the hardness of the device was checked and fulfilled the specifications. Based upon this information, the complaint is rated as confirmed, but not valid from the manufacturing point of view. No manufacturing related issues were identified and/or confirmed. Product investigation summary: based upon the provided information, it is impossible to determine the exact cause for this occurrence. However, it is likely that wear and tear over the years and/or high applied mechanical force led to this damage. No product fault could be detected. (b)(4) additional medical intervention required to retrieve the broken pieces of the instrument. The event resulted in a thirty (30) minute surgical prolongation. 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.
 
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Brand NameAWL Ø16.5/3.2 CANN
Type of DeviceAWL
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5631540
MDR Text Key44407037
Report Number9612488-2016-10222
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.365
Device Lot Number2666723
Other Device ID Number(01)07611819326927(10)2666723
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/04/2016 Patient Sequence Number: 1
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