MAUDE Adverse Event Report: SYNTHES GMBH TI SNAP-ON TRANSCONNECTOR 30MM-33MM FOR 5.5MM/6.0MM RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 04.633.330S

Device Problem Material Integrity Problem (2978)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported during a spinal fusion performed on (b)(6), 2021, when the transverse connector was being deployed, one of the components came off.No fragment was left in the lesion.The procedure was completed less than thirty (30)-minute surgical delay.Patient outcome is reported as stable.No further information is available.This report is for one (1) ti snap-on transconnector 30mm-33mm for 5.5mm/6.0mm rods this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional device product codes: mni; mnh; kwp; kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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 product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the snap-on transverseconnector l30-33 f/r ø had no product issues or defects.An unknown ring component was returned along with the device and could not be identified to be a part of the snap-on transverseconnector l30-33 f/r ø.No issues were identified with the returned device.The dimensional inspection was not performed due to the complex geometry of the device.A functional test was performed on the returned device.The sliding mechanism functioned as intended, the t-rod was able to move back and forth with no issues.All three screws were able to be tighten and loosened with no issues.When the translation screw is tightened the slide mechanism will remain in place and would not slide, when loosened the slide mechanism would move freely.The device functioned as intended.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint could not be confirmed for the snap-on transverseconnector l30-33 f/r ø as it was observed to function as intended and the ring component returned along with the device could not be identified to be a component of this device.A definitive root cause could not be determined for the reported complaint condition from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed- the following drawings reflecting the current and manufactured revisions were reviewed.Device history lot - part #: 04.633.330s, lot #: 8l40948, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 22 jul 2021, expiry date: 01 jul 2031.Non-sterile part: part #: 04.633.330 , lot #: 93p3502, jbrown elmira 17-jan-2022.Part number: 04.633.330s, lot number: 93p3502, part manufacture date: 26-feb-2021, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of snap-on transverseconnector l30-33 f/r ø product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review - this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that 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.

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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: TI SNAP-ON TRANSCONNECTOR 30MM-33MM FOR 5.5MM/6.0MM RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13253192
• MDR Text Key: 289503672
• Report Number: 8030965-2022-00318
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819366275
• UDI-Public: (01)07611819366275
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.633.330S
• Device Lot Number: 93P3502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1