MAUDE Adverse Event Report: SYNTHES GMBH SPEED SHIFT 20X20X20 OFFSET 10MM IMPLANT; STAPLE, FIXATION, BONE

Model Number	SE-2020-10
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Additional narrative: reporter is a j&j employee.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 it was discovered three speed shift cci implants (se-2020-10) that had the wrong drill guide.The drill guide in the packaging was for a 15-06 offset or product code se-1520-06.The correct drill guide should be for a se-2020-10.These were found in in inventory before being deployed to a case and there was no direct impact on patients, surgery or customers.This report involves one (1) speed shift 20x20x20 offset 10mm implant.This is report 2 of 3 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.H3, h6: part #: se-2020-10 synthes lot #: mse210237 supplier lot #: mse210237 release to warehouse date: 07 mar 2022 supplier: (b)(4).No ncr's 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 conducted a visual inspection of the returned device.Photos of the item was received as well and only can be observed the label on the back of the boxes.Visual analysis of the returned sample revealed that speedshift comp impl kit 20x20x20 ofst10.It was confirmed that the 15-06 drill guide, to be use with the product code se-1520-06, was packaged with the product se-2020-10 in a speedshift comp impl kit 20x20x20 ofst10 box.A dimensional inspection for the speedshift comp impl kit 20x20x20 ofst10 was unable to be performed due to basic dimension are irrelevant to reported 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 speedshift comp impl kit 20x20x20 ofst10.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the speedshift comp impl kit 20x20x20 ofst10 confirmed that the 15-06 drill guide, to be use with se-1520-06, was packaged with the product se-2020-10 in a speedshift comp impl kit 20x20x20 ofst10 box.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 SHIFT 20X20X20 OFFSET 10MM IMPLANT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15625121
• Report Number: 8030965-2022-08338
• Device Sequence Number: 6184137
• Product Code: JDR
• UDI-Device Identifier: 00810633020494
• UDI-Public: 00810633020494
• Combination Product (Y/N): N
• 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,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-2020-10
• Device Catalogue Number: SE-2020-10
• Device Lot Number: MSE210237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown