MAUDE Adverse Event Report: SYNTHES GMBH SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT; STAPLE, FIXATION, BONE

Model Number SE-1520-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that on an unknown date, the staples were off the inserter.This report involves one speed shift 15x20x20 offset 10mm implant.This is report 2 of 2 for (b)(4).

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.Date of event: only the event year is known.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The initial reporter is a j&j employee.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the speedshift comp impl kit 15x20x20 ofst 10 had the staple unattached inside the sealed package, this condition is most likely due to breakage of the clamps, staple and fragment are visible in the evidence provided.The observed condition of the speedshift comp impl kit 15x20x20 ofst 10 was consistent with a design related issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.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 15x20x20 ofst 10.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: SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT
• Type of Device: 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: 15896314
• MDR Text Key: 307794350
• Report Number: 8030965-2022-10509
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020449
• UDI-Public: 00810633020449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE-1520-10
• Device Catalogue Number: SE-1520-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SPEEDSHIFT COMP IMPL KIT 15X20X20 OFST 8.