MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR FRAME CRANIAL/CAUDAL

Catalog Number	03.615.100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 is expected to be returned for manufacturer review/investigation but has not been received yet.Reporter is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 retractor frame cranial/caudal is not holding.It is unknown when and how the malfunction was discovered.It is unknown if there was patient and procedural involvement.This report is for one (1) retractor frame cranial/caudal.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 03.615.100, lot# t951344.Manufacturing location: (b)(4), release to warehouse date: dec 10, 2010.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.Product investigation was completed.The implant was received with the reported condition of ¿device interaction (2+ devices) unable to assemble: rm¿ investigation flow device interaction/functional was performed.The returned implant was visually inspected, and no damage was seen on any component of the device.There were no dents/scratches on the ratcheting portion of the instrument.A functional test was done, and the device functioned as intended.All components moved freely and held in place when locked appropriately.The received condition does not agrees with the complaint description.The complaint condition could not be replicated, and no issues were detected.The complaint could not be confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.No known patient involvement reported.The device was received and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 further reported that there was no known patient involvement and there was no disruption of surgery happened.

• Brand Name: RETRACTOR FRAME CRANIAL/CAUDAL
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7794764
• Report Number: 2939274-2018-53369
• Device Sequence Number: 19155075
• Product Code: GAD
• UDI-Device Identifier: 10705034715360
• UDI-Public: (01)10705034715360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2018

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: 03.615.100
• Device Lot Number: T951344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 09/25/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1