MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MAXFRAME(TM) STANDARD STRUT/XX-SHORT; APPLIANCE,FIXATION,NAIL

Catalog Number 03.312.814

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 one (1) maxframe strut with quick adjust medium, four (4) maxframe strut with quick adjust x-short, one (1) maxframe standard short, one (1) maxframe standard x-short, two (2) maxframe standard xx-short, had a substance down at the thread.The occurrence of the event was unknown.The issue was discovered during inspection.There was no patient involvement reported.Upon the receipt of the devices, during preliminary inspection, it was noted that two (2) maxframe standard xx-short and three (3) maxframe strut with quick adjust x-short were loose.This report is for one (1) maxframe standard strut xx-short.This is report 1 of 5 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.Device history records review was completed for part: 03.312.814, lot: h385422.Manufacturing location: brandywine, manufacturing date: jun 09, 2017 no non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Slight discoloration on first 5 threads of the threaded rod component (03.312.814.3) starting at clevis component (03.312.810.15).Discoloration is a sticky substance.Related to complaint condition.Functional inspection was completed.The strut was extended/retracted through its full range of length and the assembly of the clevis and threaded rod components was checked for looseness.It was noted that functionality of product was not affected by the complaint condition.The clevis and threaded rod were found to no longer be completely tight and could rotate about 1/8 turn.The received condition agreed with the complaint description; the complaint was replicated with the returned device.Relevant drawings were reviewed.No design issues were noted during review.Conclusion the complaint conditions of a foreign substance on the thread and clevis and received condition of a loose clevis were confirmed during investigation.Upon further analysis it was determined not to be related to the manufacturing process for the following reason: there were no non-conformances during the production of the compliant products.The product passed all inspection criteria and was found to be within specifications at the time it was released to the warehouse.The inspection process for the complaint product numbers includes a 100% functional check, and a 100% check for visual nonconformities.None were present for the complainant lot.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.As events preceding the issues were unknown, a root cause could not be determined.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: MAXFRAME(TM) STANDARD STRUT/XX-SHORT
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8311618
• MDR Text Key: 135521137
• Report Number: 8030965-2019-60701
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334107541
• UDI-Public: (01)07612334107541
• Combination Product (y/n): N
• PMA/PMN Number: K161417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.312.814
• Device Lot Number: H385422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 02/07/2019
• Patient Sequence Number: 1