MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDARC COMPRESSION IMPL KIT 11X12X10; STAPLE, FIXATION, BONE

Model Number SE-111210A

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.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.

Event Description

It was reported that on (b)(6) 2021, the speedarc compression inplant kit staple was discovered as not centered or straight on insertion handle.Product was not used or opened.No patient consequence reported.This report is for one (1) speedarc compression impl kit 11x12x10.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 - codes updated to imdrf codes.Visual inspection: the complaint device speedarc compression impl kit 11x12x10 (product code: se-111210a, lot number: bse180997) was returned to cq west chester for investigation.During visual inspection, no issues were found on the device.Functional test: the implant was found not properly assembled on the inserter handle inside the packaging.Can the complaint be replicated with the returned device(s)? the complaint can be replicated as a functional test was not performed.Dimensional inspection: complaint relevant dimensions could not be measured from the device because of the design.Document/specification review: the manufactured revision of the item could not be retrieved, hence the most recent version of the drawing were reviewed.Conclusion: the implant was misaligned on the inserter.Hence, a functional test was not performed, and complaint could not be confirmed.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 was opened to address the design remediation of all bme product lines.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - no ncr's generated during production.Device history review - 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 11X12X10
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12804580
• MDR Text Key: 285355106
• Report Number: 2939274-2021-06662
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021415
• UDI-Public: (01)00810633021415
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2023
• Device Model Number: SE-111210A
• Device Catalogue Number: SE-111210A
• Device Lot Number: BSE180997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 12/16/2021
• Supplement Dates FDA Received: 12/10/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SPEEDARC COMPRESSION IMPLANT KIT 11X12X10MM; UNK - NAIL INSERTION HANDLES