MAUDE Adverse Event Report: SYNTHES GMBH SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10; STAPLE, FIXATION, BONE

Model Number	SE-2020-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
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.Reporter is a synthes employee.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 or Problem Description
Device report from switzerland reports an event as follows: it was reported that during loan set inspection at dc on (b)(6) 2022, the bone staple was broken inside the original packaging.The defect was noticed through the viewing window.This report is for a speedshift comp impl kit 20x20x20 ofst10.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: se-2020-10, lot : bse180401, release to warehouse date : 20.Aug.2018, expiration date : 23.Apr.2023, supplier: (b)(4).Manufacturing site: werk selzach, 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 the speedshift comp impl kit 20x20x20 ofst10 had broken a part of the insertion stick body implant.The device condition can be observed to be broken and the staple deployed inside its original sealed packaging.A dimensional inspection for the speedshift comp impl kit 20x20x20 ofst10 was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the speedshift comp impl kit 20x20x20 ofst10 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this 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: d4: expiration date added.D9: device returned.H4: manufacture date added.H3, h4, h6: part number: se-2020-10, bme lot number: bse180401, manufacturing date: 20 aug 2018, manufacturing site: biomedical enterprises, san antonio, tx,, expiration date: 23 apr 2023.Dhr review: no ncmrs 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 subcomponents, 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 photo.Visual analysis of the photo revealed that speedshift comp impl kit 20x20x20 ofst10 had broken a part of the insertion stick body implant.The device condition can be observed to be broken and the staple deployed inside its original sealed packaging.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 as the observed condition of the speedshift comp impl kit 20x20x20 ofst10 in the photo would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, 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.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, a change order was released on august 23, 2018 with an update to the packaging traveler for speed implants, indicating to package the loaded inserter with the release button facing down, instead of facing up, to avoid the tray pushing on.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10
• 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: 15874048
• Report Number: 8030965-2022-10303
• Device Sequence Number: 16767271
• Product Code: JDR
• UDI-Device Identifier: 00810633020494
• UDI-Public: (01)00810633020494
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 04/23/2023
• Device Model Number: SE-2020-10
• Device Catalogue Number: SE-2020-10
• Device Lot Number: BSE180401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/20/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/04/2023; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown