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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 340/LEFT - SILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 340/LEFT - SILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.055S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 09/17/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device history lot: manufacturing location: (b)(4). Manufacturing date: 28-jun-2021. Expiration date: 31-may-2031. Part number: 04. 037. 055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile. Lot number: 231p190 (sterile). Production order traveler met all inspection acceptance criteria. Inspection sheet, in-process / inspect dimensional / final, nonconformance review met all inspection acceptance criteria. Inspection sheet, tfna assembly inspection, nonconformance review met all inspection acceptance criteria. Packaging label log (pll) was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. Scn supplied by ethicon (abq) was reviewed and determined to be conforming. This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿surgeon perforated the femoral neck with the helical blade¿ does not indicate breakage of the nail or any of its components. Therefore, review of the raw materials would not be pertinent to the reported complaint condition. Device history review: this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 that on (b)(6) 2021, during an unknown procedure, while inserting a tfna nail, the surgeon perforated the femoral neck with the helical blade. The nail and helical blade were extracted, and reinserted. The helical blade was repositioned in the femoral neck and the surgery was completed successfully. During extraction, one of the prongs of the connection interface was slightly bent; however the nail was successfully reconnected and inserted. There was a (15) minute surgical delay. The procedure was successfully completed with no patient consequences. This report is for (1) 10/130 deg ti cann tfna 340/left - sile. This is report 2 of 2 for (b)(4).
 
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Brand Name10/130 DEG TI CANN TFNA 340/LEFT - SILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12639940
MDR Text Key276652241
Report Number2939274-2021-06126
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
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 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.055S
Device Catalogue Number04.037.055S
Device Lot Number231P190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2021
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: 10/15/2021 Patient Sequence Number: 1
Treatment
RIA 2 BONE HARVESTING KIT 520MM STERILE; TFNA FENESTRATED HELICAL BLADE 75 - SILE
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