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

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).

• Brand Name: DISTRACTOR FOR 11MM ROD
• Type of Device: TRACTION, 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 Key: 10822743
• MDR Text Key: 216177289
• Report Number: 2939274-2020-05099
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982006608
• UDI-Public: (01)10886982006608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD393.640
• Device Catalogue Number: SD393.640
• Device Lot Number: 20P0884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1