MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDING CARRIAGE; TRACTION,APPARATUS,NON-POWERED

Catalog Number	394.43
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.Product development investigation was completed.Visual inspection of the returned device performed at customer quality (cq) confirmed the condition of two devices being stuck together, which agrees with the reported complaint condition.The two devices were unable to be separated at cq.Therefore, the reported complaint condition is confirmed and was able to be replicated at cq.Relevant drawings were reviewed during this investigation.Based on the etchings on the device, it can be determined that it was made prior to the oldest available drawings for this part in synthes systems.Based on the etchings on the returned device, it can be determined that it was made prior to may 21, 1999.Therefore, it is over 19 years old.No product design issues or discrepancies were observed.Device history records review could not be completed as device was manufactured before 1998.A relevant dimensional inspection could not be performed at cq because the features of interest are not accessible as the two devices were returned stuck together.A definitive root cause for the devices becoming stuck together could not be determined based on the provided information.The most likely cause is over tightening leading to a cross threading situation.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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
(b)(6) reports following: it was reported that during sterile processing department (spd) inspection on an unknown date, the sliding carriage was noted to be cross threaded and seized on two (2) holding sleeves and a schanz screw blunted trocar.There was no patient involvement.During manufacturing investigation, the condition of two devices being stuck together was confirmed, which agrees with the reported complaint condition.This report is for one (1) sliding carriage.This is report 2 of 2 for (b)(4).
Event or Problem Description
During manufacturer¿s preliminary analysis of the returned devices it was noted that wing nut of another holding sleeve had broken off and the schanz screw was noted to be stripped and bent.
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.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.

• Brand Name: SLIDING CARRIAGE
• Common Device Name: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7841673
• Report Number: 2939274-2018-53574
• Device Sequence Number: 1986567
• Product Code: HST
• UDI-Device Identifier: 10886982199713
• UDI-Public: (01)10886982199713
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 394.43
• Device Lot Number: 2019.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1