MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPL KIT 25X20X20; ORTHOPAEDIC BONE STAPLE, NON-ADJUSTABLE

Model Number	SE-2520TI
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during inventory on (b)(6) 2022, it was observed that the bme speedtitan se-2520ti implant sticker and implant were in a speedtitan se-2020ti box.There was no procedure nor patient involvement reported.No additional information was provided.This complaint involves one(1) device.
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.Occupation: reporter is a j&j sales representative.The 510(k) is unknown.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g4 h3, h6: part: se-2520ti.Synthes lot: mse200194.Supplier lot: mse200194.Release to warehouse date: march 24, 2021.Manufactured by: n/a.Supplier: millstone medical.No nonconformance reports (ncrs) generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to millstone medical which conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on speedtitan compression impl kit 25x20x20.It was confirmed that the bme speedtitan se- 2520ti product had the correct label on the back of the box with correct part number and the implant was also for se-2520ti part number but the packaging was specifying that the product is in a speedtitan se-2020ti box.The dimensional inspection was not performed since dimensions are not relevant to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the speedtitan compression impl kit 25x20x20.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the speedtitan compression impl kit 25x20x20 confirmed that the bme speedtitan se- 2520ti product had the correct label on the back of the box with correct part number and the implant was also for se-2520ti part number but the packaging was specifying that the product is in a speedtitan se-2020ti box.Relevant actions have been taken to further evaluate and determine the manufacturing error in detail that led to the complaint condition.Drawing/specifications reviewed.The following drawing/documents were reviewed by millstone medical: speed titan(tm) implant kit.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.G1.H5.

• Brand Name: SPEEDTITAN COMPRESSION IMPL KIT 25X20X20
• Common Device Name: ORTHOPAEDIC BONE STAPLE, NON-ADJUSTABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14270357
• Report Number: 2939274-2022-01583
• Device Sequence Number: 20294277
• Product Code: JDR
• UDI-Device Identifier: 00810633021576
• UDI-Public: 00810633021576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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-2520TI
• Device Catalogue Number: SE-2520TI
• Device Lot Number: MSE200194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown