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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SALZBURG TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES SALZBURG TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.000S
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Device has not been reported as explanted. (b)(6). Subject device has been received and is currently in the evaluation process. Part number: 04. 019. 000s, synthes lot number: 5936231: release to warehouse date: october 7, 2015. Mfg. 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. 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)(4) reports an event in the (b)(6) is as follows; it was reported that the surgeon had problems with the titanium multiloc end cap. It was difficult to get a proper grip in the 8. 5mm titanium multiloc humeral nail so the surgeon left the nail in the patient without end cap. The operation time was extended thirty (30) minutes. No patient harm occurred. Concomitant devices reported: 8. 5mm titanium multiloc humeral nail left/cannulated/210mm-sterile (part # 04. 019. 210s, lot # unknown, quantity #1). This is report number 1 of 2 for com-(b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject devices. No product fault could be detected. Article 04. 019. 000s, lot 5936231. The investigation of the returned ti multiloc end cap f/multilocnail/0mm extension-sterile has shown no obvious damages or deviations. A functional test together with the responsible sustaining engineer has shown that the end cap could be inserted in a nail without any problems. The measurements of the end cap during the production of the parts have shown no deviations to the specification. The complaint condition for this part cannot be replicated. Article 04. 019. 005s, lot 5925314. The investigation of the returned ti multiloc end cap f/multilocnail/5mm extension-sterile has shown that the thread is strongly damaged and one thread flank is cracked. This is a clear indication that too much mechanical force was used during insertion of the endcap. A functional test together with the responsible sustaining engineer has shown that the end cap could be inserted despite the defective thread in a nail without any problems. The measurements of the end cap during the production of the parts have shown no deviations to the specification. The exact root cause cannot be determined. It can be assumed that the end cap was tried to insert with force and in a wrong angle into the nail which has finally let to the crack at the thread flank. Device was not implanted. (b)(4). 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 NameTI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer (Section G)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6046641
MDR Text Key58045622
Report Number3009417901-2016-10041
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.019.000S
Device Lot Number5936231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/21/2016 Patient Sequence Number: 1
Treatment
8.5MM NAIL (PART # 04.019.210S)
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