MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 55MM; GUIDE

Catalog Number	394.45
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 394.450, lot# 2241695.Manufacturing location: (b)(4), release to warehouse date: jan 18, 2007.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The customer reported the threads were deformed and would not accept the thumbscrew.The repair technician reported the threads were burred, and the screw was missing.Burred is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.The returned device was examined, and the deformed thumb screw complaint condition was confirmed.The device cannulation has significantly deformed threads throughout the thread cannulation.Furthermore, an unknown metal piece was observed lodged in about half portion of the given thread cannulation.The other half of the cannulation has burred regions with all thread portions deformed and stripped off.Additionally, rounded cannulation was noted at its top edge.No new issues were identified.Functional inspection and complaint condition replication was not able to be performed as the mating wing screw was not returned at customer quality.However, with the observed deformation the complaint condition was confirmed.Relevant drawings for the returned device were reviewed and no design issues were noted.Dimensional analysis performed accepted the gage pin diameter 4.00 mm that falls out of the specification of m5 thread specification.(dia 4.459 mm to 4.675 mm for coarse pitch).The out of tolerance is due to post manufacture damage.Per device history records review, no issues during the manufacture of this product which would contribute to this complaint condition were identified.Furthermore, with the age of the device (over 14 years) there is no indication that the device material would have contributed to the complaint condition.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, it is possible that any off-axis threading with any unintended forces could have caused both thread deformation and mating device damage which in turn led to this complaint condition.This complaint was confirmed; however, no product design issues or manufacturing discrepancies were identified.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 the threads of the thumb screw in femoral holding sleeves 55mm and 105mm had deformed and would not accept the thumb screw.It was unknown if there was patient and surgical procedure involved.During investigation, it was noted that holding sleeves 55mm was deformed.This report is for one (1) holding sleeve 55mm.This is report 1 of 6 for (b)(4).

• Brand Name: HOLDING SLEEVE 55MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7898097
• Report Number: 2939274-2018-53898
• Device Sequence Number: 16172725
• Product Code: FZX
• UDI-Device Identifier: 10886982199737
• UDI-Public: (01)10886982199737
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/25/2018

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 Catalogue Number: 394.45
• Device Lot Number: 2241695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1