MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STAPLE IMPACTOR FOR 6.0MM-8.0MM STAPLES

Catalog Number	385.807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that patient underwent a spinal fusion on (b)(6) 2018.During impaction, the staple impactor broke.A piece into the patient but was retrieved.No patient consequence was reported.Concomitant device: mallet/hammer (part unknown, lot unknown, quantity 1).This report is for one (1) staple impactor.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 device history record (dhr) review was conducted: part: 385.807, lot: 8827354, manufacturing site: haegendorf, release to warehouse date: 19.May 2014.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all functional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: visual inspection of the returned device revealed one of the collet subcomponent¿s (agile item number 50140151) four tangs broke at its base.The broken piece was received with the device.Based on visual inspection, the received condition of the device agreed with the complaint description.The complaint condition was confirmed.No other damage was noted to the any other feature of any other component besides cosmetic wear consistent with use.Dimensional inspection: the inner diameter of the collet¿s distal cannulation measured and is within specification.The inner diameter of the proximal cannulation measured and is within specification.The outer diameter along the slotted shaft feature measured and is within specification.All specifications were per relevant drawing; inner diameter dimensions were taken using gauge pins; outer diameter dimension was taken using caliper.The diameter of the ramp/expansion feature of the inner shaft/locking tip component (agile item number 50140150) to which the collet assembles onto measured and is within specification per relevant drawing.An allegation against this component was not made, however, a measurement above specification of this feature could contribute to the condition of the collet.Document/specification review: the relevant drawings were reviewed during investigation: dhr review: device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: the complaint condition was confirmed.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A root cause could not be determined as the event conditions were unknown.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.

• Brand Name: STAPLE IMPACTOR FOR 6.0MM-8.0MM STAPLES
• Common Device Name: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8066403
• Report Number: 2939274-2018-54967
• Device Sequence Number: 2701884
• Product Code: HWA
• UDI-Device Identifier: 10705034770888
• UDI-Public: (01)10705034770888
• 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): 10/28/2018

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: 385.807
• Device Lot Number: 8827354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 10/28/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1