MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 13X10X10MM; BONE STAPLE

Model Number	SE-1310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Reporter is a synthes employee.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
It was reported that on an unknown date, one (1) speed compression implant kit and one (1) speed compression set were compromised upon opening.The staple fell off the handle in the package.It is unknown if there was a surgical delay.Procedure outcome is unknown.No patient impact as there was an additional one.This report is for one speed compression implant kit 13x10x10mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
Update 1/21/2020: it was reported that the staple was not loaded on the handle.The staple was never put near the patient.We were able to just open another package.Surgery was successful for the bunionectomy.The staple had already projected off the handle.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: device history lot: part number: se-1310, bme lot number: bse180748, manufacturing date or release to warehouse date: 28 sep 2018, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 01 aug 2023.Dhr review: no non-conformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Device history batch null, device history review.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.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 13X10X10MM
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9588134
• Report Number: 2939274-2020-00185
• Device Sequence Number: 14353379
• Product Code: JDR
• UDI-Device Identifier: 00810633020142
• UDI-Public: (01)00810633020142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Expiration Date: 08/01/2023
• Device Model Number: SE-1310
• Device Catalogue Number: SE-1310
• Device Lot Number: BSE180748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/10/2020
• Patient Sequence Number: 1