MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDARC IMPLANT SIZING GUIDE; STAPLE, FIXATION, BONE

Model Number	SG-3
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
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a routine incoming inspection of a loaner set, a speedarc implant sizing guide was damaged and broken.There was no known patient or hospital involvement.This report is for one (1) speedarc implant sizing guide.This is report 1 of 1 for (b)(4).
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, h4, h6: a review of the device history record.Device history lot part number: sg-3, synthes lot number: bsg170073 , supplier lot number: n/a, release to warehouse date: 22 mar 2017, expiration date: n/a, supplier: (b)(4).Ncmr #3028 was generated during production for (b)(4) parts.During assembly process of sg-3 in clean room, noticed.Wet lab had crossed over one sg-3 with broken tine.This part was scrapped and (b)(4) parts were released.Relevance to complaint condition cannot be determined until the product is returned for investigation.Device history batch null, device history review review of the device history record showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: investigation summary it was reported that during a routine incoming inspection of a loaner set on an unknown date, a speedarc implant sizing guide was damaged and broken.There was no known patient or hospital involvement.Investigation flow: labeling & packaging.Visual inspection: nothing is broken with the instrument, instead the original packaging the instrument is enclosed in is bent/crushed along several sections.One of the corners of the top tuck flap is teared slightly.The shrink wrap is still intact, the sterility barrier has not been breached.Document review: document review was not performed because it was not relevant to complaint condition.A manufacturing record evaluation (mre) was performed for the returned instrument¿s lot number and no mrrs, ncs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Dimensional analysis: dimensional analysis was not performed because it was not relevant to complaint condition.Conclusion: the complaint condition is unconfirmed for broken, instead there is damage to the package.While no definitive root cause could be determined it is possible that the device encountered rough handling during shipment/handling resulting in the complaint condition.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.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: SPEEDARC IMPLANT SIZING GUIDE
• 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: 9982630
• Report Number: 2939274-2020-01969
• Device Sequence Number: 11851025
• Product Code: JDR
• UDI-Device Identifier: 00810633021583
• UDI-Public: 00810633021583
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: SG-3
• Device Catalogue Number: SG-3
• Device Lot Number: BSG170073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1