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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF HYBRID INSERTION HANDLE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES HAGENDORF HYBRID INSERTION HANDLE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.011
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2017
Event Type  malfunction  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. H10 additional narrative: patient¿s weight is unknown. Device is an instrument and is not implanted/explanted. A device history record (dhr) review was performed for part # 03. 037. 011 lot # 9561879: manufacturing site: (b)(4), manufacturing date: 12. Aug. 2015: no non conformance reports (ncrs) 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. A product development investigation was performed. This complaint is confirmed for hybrid insertion handle (part # 03. 037. 011 lot # 9561879). Device was received at customer quality (cq) with driving cap (part # part#03. 010. 523, lot # 9645724) partially threaded into it and stuck/seized together. The two (2) devices were unable to be separated (unthreaded) at cq. The driving cap is not exactly perpendicular to the handle and therefore it is suspected that the two devices have become cross-threaded together. Whether this complaint can be replicated at customer quality (cq) is not applicable for the complaint conditions. No new malfunctions were identified as a result of the investigation. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed for the returned devices as part of this investigation. No product design issues or discrepancies were observed. Relevant drawings were reviewed during the investigation. The root cause most likely is due to cross-threading (threading together while not properly oriented). No new, unique or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. 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
T was reported that during a revision surgery of trochanteric fixation nail advance (tfna) implants on (b)(6) 2017 the surgeon had difficulty extracting the distal portion of the broken nail. Surgeon was able to remove the distal portion of the nail using the tfna nail extractor, extractor hook and the t-handle chuck. When implanting the new tfna (14mm/130° titanium cannulated 380mm/left - sterile) the driving cap cross threaded into the hybrid insertion handle. Cross threading obstructed lateral views of the hip and delayed locking of the helical blade. The connecting screw would not retain on the ball hex screwdriver, falling onto the floor. The t-handle chuck bent making it difficult to advance and retract the 2. 5 reaming rod. The surgeon also stated that during the revision a locking screw depth gauge gave false measurements, requiring a screw to be removed and replaced for a correct length screw. The surgery was delayed by 120 minutes and required additional x-rays were taken. During manufacturer investigation process it was identified that the returned hybrid insertion handle was partially threaded into the driving cap and both devices were unable to be separated. This condition was reassessed and determined to be reportable on (b)(6) 2017. This report addresses intraoperative issues during the revision surgery. The revision of the trochanteric fixation nail advance (tfna) nail (12mm/130° titanium cannulated 170mm - sterile) eight plus weeks postoperative due to broken nail has been captured in linked complaint com-(b)(4). Concomitant device reported: nail (part # 04. 037. 242s, lot # h041935, quantity 1), ball hex screwdriver (part # unknown, lot # unknown, quantity 1), reaming rod (part # unknown, lot # unknown, quantity 1) this report is for one (1) hybrid insertion handle. This is report 2 of 2 for complaint com-(b)(4).
 
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Brand NameHYBRID INSERTION HANDLE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6646297
MDR Text Key78093297
Report Number3003875359-2017-10293
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982070272
UDI-Public(01)10886982070272(10)9561879
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.011
Device Lot Number9561879
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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