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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISTRACTOR FOR 11MM ROD TRACTION, APPARATUS, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISTRACTOR FOR 11MM ROD TRACTION, APPARATUS, NON-POWERED Back to Search Results
Model Number SD393.640
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Occupation: reporter is a synthes employee. Part:sd393. 640, synthes lot: 20p0884, supplier lot: n/a, release to warehouse date: may 19, 2020, expiration date: n/a, supplier: jabil monument, no relevant non-conformances were noted. Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Visual inspection: the distractor for 11 mm rod was returned and received at us customer quality (cq). Upon visual inspection, the distal threaded tip of the distractor body component (sd393. 640. 1) was broken and the broken fragments were not returned. The remaining threads of the distractor body were observed to be deformed. There were scratches and nicks on the device but have no impact on the device functionality. No other issues were identified with the returned components of the device. Dimensional inspection: dimensional inspection of the thread was unable to be performed due to the deformity of the threaded feature but the length of the distractor body was measured to be not within the specification per drawing because of the damage. Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed. Distractor for 11 mm rod, body assembly, distractor body, no relevant non-conformances were noted. Investigation conclusion: the complaint condition was confirmed for the distractor for 11 mm rod. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. The potential cause could be due to unintended forces applied to the device. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. 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 an unknown date, the sterile processing department (spd) gave a distractor tube with a broken bolt. It is unknown if there was a patient involvement. This report is for a distractor for 11 mm rod. This is report 1 of 1 for (b)(4).
 
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Brand NameDISTRACTOR FOR 11MM ROD
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10822743
MDR Text Key216177289
Report Number2939274-2020-05099
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSD393.640
Device Catalogue NumberSD393.640
Device Lot Number20P0884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
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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