MAUDE Adverse Event Report: SYNTHES GMBH SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT; STAPLE, FIXATION, BONE

Model Number	SE-1520-06
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
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.Only the event month and year are known.Initial reporter is a j&j employee.Part number: se-1520-06.Bme lot number: bse171018.Manufacturing date or release to warehouse date: 25 jan 2018.Expiration date: 02 jan 2023.Manufacture site: biomedical enterprises, inc.San antonio, tx.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the two returned samples revealed that the speedshift comp impl kit 15x20 offset 6 had a broken prong of the inserter and the implant had been deployed inside the original sealed packaging.No other issues were identified.A dimensional inspection for the speedshift comp impl kit 15x20 offset 6 was not since it was not applicable to the complaint condition.The observed condition of the speedshift compression implant kit 15x20mm offset 6mm was consistent with a design related issue.A functional test was not performed as the device was found to be broken inside the original packaging.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the speedshift compression implant kit 15x20mm offset 6mm was observed to broken and deployed inside the original packaging.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? yes, reviewed.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, it was noticed that the inserter was cracked when restocking the speed shift tote.There was no consequence to a patient.No further information is available.This report involves one speed shift 15x20x20 offset 6mm implant.This is report 1 of 2 for (b)(4).

• Brand Name: SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16308679
• Report Number: 8030965-2023-01411
• Device Sequence Number: 6792461
• Product Code: JDR
• UDI-Device Identifier: 00810633020425
• UDI-Public: 00810633020425
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 01/02/2023
• Device Model Number: SE-1520-06
• Device Catalogue Number: SE-1520-06
• Device Lot Number: BSE171018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPEEDSHIFT COMP IMPL KIT 15X20 OFFSET 6.
• Patient Sex: Unknown