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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN RIB EXPANSION PLIERS PLIERS,SURGICAL

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SYNTHES TUTTLINGEN RIB EXPANSION PLIERS PLIERS,SURGICAL Back to Search Results
Catalog Number 388.471
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Code Available (3191)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative

Patient identifier and date of birth are not available for reporting. Patient weight in unknown, however patient is reported as very thin. Device is an instrument and is not implanted/explanted. Reporter phone number: (b)(6). A review of the device history records has been requested and is currently pending completion. The tip of the rib distractor pliers broke intraoperatively and generated fragments. The device tip was removed from the patient; however with difficulty. The device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 during a vertical expandable prosthetic titanium rib (veptr) ii expansion surgery performed on (b)(6) 2017, the tip of the rib expansion pliers broke after only two holes of distraction made. Fragment (device tip) was generated and it was retrieved, but with difficulty. Surgeon opened organic glue and were about to give up and let the fragment inside the distraction rack of veptr covered with glue. In a last attempt surgeon was able to suck the instrument tip. Surgery was prolonged for more than 20 minutes due to attempts made by surgeon to remove the piece of the instrument from the veptr extension hole. Reportedly there was no patient harm. Patient status reported as fine. Procedure was completed successfully this is report 1 of 1 for complaint (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part# 388. 471, lot# a7qa46. Manufacturing location: (b)(4), manufacturing date: nov 20, 2007. No non conformance reports were generated during production. Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records, certification test values and acceptance criteria. All 32 parts of the lot were checked 100% for ctq features and for function at the final inspection on 19-nov-2007. 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

Device was used for treatment, not diagnosis. The visual inspection of the returned rib distraction pliers has shown, that the pin on top of the instrument is completely broken off. There are also scratches and wear marks on the whole item visible. Additional it was also found, that the spring is bent and this is the reason that the instrument does not work as intended. Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records, certification test values and acceptance criteria. Unfortunately, we are not able to determine the exact cause which has lead to this occurrence. As this instrument is more than 9 years old, we suppose that the breakage were caused due to normal wear and tear over the years. The relevant dimension could not be measured as the pin of the rib distraction pliers is completely broken off. 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 NameRIB EXPANSION PLIERS
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6527499
MDR Text Key73872324
Report Number9680938-2017-10072
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 04/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number388.471
Device LOT NumberA7QA46
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/20/2007
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: 04/27/2017 Patient Sequence Number: 1
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