MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 11X10X10MM; STAPLE, FIXATION, BONE

Model Number SE-1110

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/20/2022

Event Type  malfunction  

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.Additional narrative: investigation summary: 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 returned sample revealed that speed compression implant kit: 11x10x10mm was observed its original sealed package and the implant was deployed from the inserter and was freely moving inside the package.The dimensional inspection was not performed as this is a known issue addressed under capa-007630.The observed condition of the speed compression implant kit: 11x10x10mm was consistent with a design related issue.A functional test was not performed as the device was found 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 for speed compression implant kit: 11x10x10mm as the implant is disengaged from it's insert while still in the unopened package; however, the condition of the complaint device is consistent with prior issues with the same occurrence.This is addressed with capa-007630.Based on the investigation conducted, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.Capa-007630 is open to address the design remediation of all bme product lines, which encompasses the design upgrade of speed from the current button inserters to slider inserters.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Drawing/specifications reviewed: yes, no issues dimensional inspection: device history: part # se-1110; synthes lot #: bse180612; supplier lot #: bse180612; release to warehouse date: 10 sep 2018.Supplier: biomedical enterprises, inc.No ncr's were 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.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 Description

It was reported that on may 20, 2022, upon organizing bme staples in preparation for surgeons' scaphocapitate fusion case, it was discovered that one of the bme speed implants had deployed inside of its packaging, seals still intact.This implant was not needed during the case.There was no patient consequences.This is report 1 of 1 for (b)(4).This report is for a speed compression implant.

• Brand Name: SPEED COMPRESSION IMPLANT KIT 11X10X10MM
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 14986178
• MDR Text Key: 304375638
• Report Number: 2939274-2022-02605
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020128
• UDI-Public: (01)00810633020128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE-1110
• Device Catalogue Number: SE-1110
• Device Lot Number: BSE180612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male