MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 20X20X20MM; STAPLE,FIXATION,BONE

Model Number	SE-2020
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(4).Patient gender and weight not available for reporting.Device is a kit, which includes both the insert mechanism and the staple.Only the staple was implanted on (b)(6) 2018 and was not explanted.The insert mechanism is expected to be returned for investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an unknown procedure to implant a speed titan se-2020 bone staple on (b)(6) 2018, it was noted that the handle of the device was cracked directly above the release mechanism.The surgeon elected to continue using the device; however, found it challenging to release the staple from the insertion handle.The procedure was completed successfully; however, there was a 30 second delay noted due to the damaged device.No adverse events were reported against the patient.This report is for one (1) speed compression implant kit.(b)(4).
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.
Additional Manufacturer Narrative
Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Corrected data: udi.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.Customer quality conducted an investigation of the returned device.The device was returned to and investigated by bme with the following results; visual inspection of the returned device showed the inserter was broken in half on its merged leg side.Dimensional inspection was made to verify inserter was within specified manufacturing dimensions.Inserter passed all measurable dimensions, dimension h could not be measured due to the state of the inserter, nonetheless, this dimension would not contribute to the breakage of the component, since it is a required dimension to make sure the inserter fits in its packaging.After physical inspection of the returned device, it was concluded that the breakage cannot be attributed to manufacturing.Visual and dimensional inspection showed that all components met all dimensional and visual criteria.Root cause for the breakage cannot be confirmed based on the information provided on this complaint.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.Appropriate steps have been taken to address the transfer from supplier protolabs and the redesign of all bme components.No further corrective action for this situation is deemed necessary at this moment.Conclusion: the complaint condition is confirmed as the device inserter is broken.Replication of the complaint condition is not applicable as the inserter is already broken.A root cause could not be definitively determined.No manufacturing related issue was identified and/or confirmed.The potential impact of the design in the complaint condition is currently being addressed.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: SPEED COMPRESSION IMPLANT KIT 20X20X20MM
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7349890
• Report Number: 2939274-2018-51104
• Device Sequence Number: 679709
• Product Code: JDR
• UDI-Device Identifier: 00810633020227
• UDI-Public: (01)00810633020227(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2018

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 Model Number: SE-2020
• Device Catalogue Number: SE-2020TI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 04/20/2018; 05/17/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/18/2018; 04/24/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR