MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM TROCAR 232MM; GUIDE

Model Number	357.383
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 on an unknown date during routine incoming inspection a loaner set at fsl ups malden, ma site, it was observed that a trocar was broken.There was no known patient or hospital involvement.This is report 1 of 1 for (b)(4).
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.A product investigation was conducted.Visual inspection: the received device was found slightly bent at the middle of the trocar wire.There was nothing found broken off the device.Hence complaint can not be confirmed for the broken condition of the device.Dimension inspection: the diameter of the trocar wire was measured and is within specification per relevant drawing.Conclusion: the complaint is not confirmed.No definitive root cause could be determined for bent condition.However, it is likely that the device experienced excessive force during uses.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part number: 357.383.Synthes lot number: 5525042.Supplier lot number: n/a.Release to warehouse date: (b)(6) 2007.Expiration date: n/a.Manufactured by synthes brandywine.No ncrs were generated during production.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.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: 3.2MM TROCAR 232MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9316475
• Report Number: 2939274-2019-62151
• Device Sequence Number: 16283645
• Product Code: FZX
• UDI-Device Identifier: 10886982196118
• UDI-Public: (01)10886982196118
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 10/28/2019

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: 357.383
• Device Catalogue Number: 357.383
• Device Lot Number: 5525042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1