MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ADJUSTABLE LARGE FIXATOR; APPLIANCE,FIXATION,NAIL

Model Number	392.961
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Without a lot number the device history records review could not be completed.Customer quality conducted an investigation of the returned device.Customer quality investigation: the following investigations were performed: broken: device condition: visual inspection performed at customer quality (cq) observed broken parallel pin portion of the adjustable fixator screw assembly.The parallel pin locks the joint lock screw and screw cap together.Half the portion of the pin is lodged in the screw cap whereas the other broken portion of the pin was also returned.Only joint lock screw, washer and the screw cap with broken pin was returned.No other assembly units of the adjustable fixator were returned.The complaint condition was not able to be confirmed.Dimensional analysis and document/specification review: due to the unavailability of lot number the exact manufacture date of the device was not able to be determined.Furthermore, approximate date range for manufacturing was not able to be estimated as the whole assembly was not returned for inspection.However, the current drawings were reviewed, and no design issues were noted.Adjustable fixator top-level; distractor join assembly sub component drawing; parallel pin.Dimensional analysis performed on the pin diameter measured 2 mm that falls within the specification 2mm (+0.002/+0.008 mm).Review of the device history record is not possible as the lot number is unknown.However visual inspection performed on the broken pin fragments under 5x magnification showed no material irregularities such as voids on the pin cross-section.Therefore, no material related issues would have contributed to this complaint condition.No definitive root cause was able to be determined.However, any unintended excessive forces encountered during screwing/ possible misalignment while screwing could have contributed to complaint condition.Conclusion: this complaint is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 or Problem Description
It was reported that during an unknown surgical procedure on (b)(6) 2018, the swivel locking screw on the adjustable large fixator came off, leaving the device in three (3) pieces.Fragments were easily removed.A large external fixator was used to stabilize the construct and complete the procedure successfully with a delay of approximately 25 minutes.Evaluation of the returned device revealed the parallel pin portion of the device is broken.This report is for one (1) adjustable large fixator.This is report 1 of 1 for (b)(4).

• Brand Name: ADJUSTABLE LARGE FIXATOR
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7876687
• Report Number: 2939274-2018-53767
• Device Sequence Number: 13968349
• Product Code: KTT
• UDI-Device Identifier: 10886982198877
• UDI-Public: (01)10886982198877
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K010344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 392.961
• Device Catalogue Number: 392.961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1