MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDARC COMPRESSION IMPL KIT 11X15X12; STAPLE, FIXATION, BONE

Model Number	SE-111512A
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, surgeon tried to place speedarc implant medially.Everything went according to stg up until the first assist.The surgeon noticed the staple inserter device had broken.This resulted in the staple deploying prematurely and compressing.With the small size of this staple it was unable to be spread open and reloaded.After dr.Tried over and over to get it in, he was forced to go to screw instead.The procedure was successfully completed with a 20 minutes of surgical delay noted.No fragments were generated.There was no patient consequences.This complaint involves one (1) device speedarc compression impl kit 11x15x12.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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: h3, h4, h6 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 speedarc compression impl kit 11x15x12 was broken a part of the insertion stick body implant.The dimensional inspection was not performed as this is a known issue addressed under capa-007630.The observed condition of the speedarc compression impl kit 11x15x12 was consistent with a design related issue.A functional test was not performed as the device was found to be broken.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the speedarc compression impl kit 11x15x12 was observed to broken.The potential impact of the design to the complaint condition is addressed under capa-007630.No further corrective action is deemed necessary at this time.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: no issues.Dimensional inspection: n/a.Device history: part # se-111512a, synthes lot # bse180279, supplier lot # bse180279, release to warehouse date: 16 aug 2018, expiration date: 19 mar 2023, 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.

• Brand Name: SPEEDARC COMPRESSION IMPL KIT 11X15X12
• Common Device Name: 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: 14305506
• Report Number: 2939274-2022-01621
• Device Sequence Number: 14780609
• Product Code: JDR
• UDI-Device Identifier: 00810633021422
• UDI-Public: (01)00810633021422
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 03/19/2023
• Device Model Number: SE-111512A
• Device Catalogue Number: SE-111512A
• Device Lot Number: BSE180279
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown