MAUDE Adverse Event Report: SYNTHES GMBH SPEED COMPRESSION IMPLANT KIT 15X12X12MM; STAPLE, FIXATION, BONE

Model Number	SE-1512
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure on (b)(6) 2022, it was noticed that the implant kit had a 13mm drill guide in the packaging.The sales rep opened another implant that contained the proper drill guide.Procedure was completed successfully with a delay of two minutes.There was no patient consequences.This report is for a speed compression implant kit 15x12x12mm.This is report 1 of 1 for (b)(4).
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Facility phone number reported as (b)(6).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: b5 d3, d10 h3, h4, h6: part # se-1512 synthes lot # mse220445 supplier lot # mse220445 release to warehouse date: 24 aug 2022 supplier: millstone medical no ncrs 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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photo.Visual analysis of the photo was performed on speed compression implant kit 15x12x12mm.It was confirmed that the 13mm drill guide instead of a 15mm was packaged with the product product se-1512 in a speed compression implant kit 15x12x12mm box.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 speed compression implant kit 15x12x12mm.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the speed compression implant kit 15x12x12mm confirmed that the 13mm drill guide instead of a 15mm was packaged with the product product se-1512 in a speed compression implant kit 15x12x12mm box.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
This is report 1 of 2 for (b)(4).
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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo was performed on speed compression implant kit 15x12x12mm.It was confirmed that the 13mm drill guide instead of a 15mm was packaged with the product product se-1512 in a speed compression implant kit 15x12x12mm box.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 speed compression implant kit 15x12x12mm.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the speed compression implant kit 15x12x12mm confirmed that the 13mm drill guide instead of a 15mm was packaged with the product product se-1512 in a speed compression implant kit 15x12x12mm box.Part # se-1512, synthes lot # mse220445, supplier lot # mse220445, release to warehouse date: 24 aug 2022, supplier: (b)(4).No ncrs were generated during production.It 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: SPEED COMPRESSION IMPLANT KIT 15X12X12MM
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15473011
• Report Number: 8030965-2022-07266
• Device Sequence Number: 11481494
• Product Code: JDR
• UDI-Device Identifier: 00810633020166
• UDI-Public: (01)00810633020166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup,Followup

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 Model Number: SE-1512
• Device Catalogue Number: SE-1512
• Device Lot Number: MSE220445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 11/01/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/17/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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: SPEED COMPRESSION IMPLANT KIT 15X12X12MM
• Patient Sex: Unknown