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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM THREADED SPINDLE 330MM TRACTION,APPARATUS,NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM THREADED SPINDLE 330MM TRACTION,APPARATUS,NON-POWERED Back to Search Results
Model Number 394.41
Device Problem Naturally Worn
Event Date 07/01/2019
Event Type  Malfunction  
Manufacturer Narrative

Without a lot number, the device history records review could not be completed as no product was received. Investigation summary background: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) of the distal tibia for primary fixation of a fracture. During the surgery, it was noted that the threads on the threaded spindle were stripped, so it was not allowing an unknown spindle nut to spin on the threads. The procedure was completed successfully using the other bar that was in the set. There was no surgical delay. Patient outcome was good. Concomitant devices reported: unknown spindle nut (part # unknown, lot # unknown, quantity unknown). This complaint involves one (1) device. Investigation flow: damage. Visual inspection: the 14. 0 mm threaded spindle 330 mm (p/n: 394. 41, lot: unk) was received showing stripped threads. Based on the exhibited damage it is likely that the part has been heavily used in the field. The returned part showed potential end of life indicator of stripped threads. Based on the laser etching on the returned spindle (without ce and lot # etch), this part was manufactured prior to se_438741 rev a (in exchange for d0003738), d0003738 rev 02, and d0003738 rev 01 (earliest available drawing in agilee system). Thus this part was manufactured prior to 01 mar 1999 and is 20+ years old. Conclusion: after a visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing (20+ years); therefore, further investigation for the reported complaint device is not required. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot a dhr review could not be performed as there is no lot # etch per design for the returned part. Device history batch null, device history review a dhr review could not be performed as there is no lot # etch per design for the returned part. 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) 2019, the patient underwent an open reduction internal fixation (orif) of the distal tibia for primary fixation of a fracture. During the surgery, it was noted that the threads on the threaded spindle were stripped, so it was not allowing an unknown spindle nut to spin on the threads. The procedure was completed successfully using the other bar that was in the set. There was no surgical delay. Patient outcome was good. Concomitant devices reported: unknown spindle nut (part # unknown, lot # unknown, quantity unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

 
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Brand Name14.0MM THREADED SPINDLE 330MM
Type of DeviceTRACTION,APPARATUS,NON-POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8833624
Report Number2939274-2019-59415
Device Sequence Number1
Product CodeHST
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number394.41
Device Catalogue Number394.41
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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