MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Break (1069)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).This report is for an unk - psi implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a surgical procedure.During the surgery, two(2) of the splints broke.The intermediate splint broke when they were wiring it.It is unknown how the procedure was completed.It is unknown if there was surgical delay.Patient outcome was unknown.Concomitant device reported: unk - cable/wire (part# unknown; lot# unknown; quantity: unknown).This complaint involves two(2) devices.This report is for (1)unk - psi implants.This report is 1 of 2 for (b)(4).

Event Description

The intermediate splint broke between the canine and the premolar on the right side.This was seen after we removed the splint when we had already plated.No time was lost but the bite may have been off because of the broken splints.The palatal splint broke about 3mm below where the wires went into the splint on the 1st molar and the 2nd premolar on the left side.The palatal splint was hitting on the palatal tissue which was blocking it from seating fully.There should be a relief area from the palatal tissue to allow for the palatal tissue to change as the maxilla is split and stretched apart.This difficulty in seating the splint caused about a 30-minute delay in surgery.The lack of a palatal splint and the broken intermediate splint did not cause immediate harm to the patient.The lack of the palatal splint will necessitate sedation and placement of the splint on the patient in the immediate post-op and healing period, which is a second procedure and painful.If it is not, correctable, it may cause the need for revision surgery if the maxilla collapses due to a lack of transverse support.

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 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: h6.Investigation summary investigation summary: according to the email from materialise, they have logged this complaint as (*b)(4).A manufacturing investigation was conducted by the legal manufacturer: materialise.Design review: during the investigation, the splint design, planning, and production steps were reviewed.The possible root cause for the breaking of the splints was reviewed.It was found that the planning could have contributed to the issue.The way the case was planned in combination with how the palatal splint was designed, very likely lead to excessive pressure from the palate onto the palatal and intermediate splint.The design of the splint met the specifications as indicated by the work instructions and no issues were detected in the production step.As multiple splints have broken, further investigation will be done in capa 1764.For this complaint, it can be concluded that the fact that it was a 3 piece maxilla with a palatal splint contributed to the breaking of the splints and the need for additional treatment with a new splint.The following actions were considered - shipping a new case with the splints needed for the treatment, added planning considerations to a dat, and capa 1764 was initiated.Conclusion: the complaint condition could be confirmed.The possible root cause could be due to the planning of the device which lead to splint breakage.Since there were multiple splint breakages, the legal manufacturer: materialise initiated capa 1764 and further investigation will be done.Additionally, johnson & johnson has initiated the nc # (b)(4) to track the materialise capa 1764.Device history lot part #: sd900.105.Lot #: mu21-iki-taq.Dhr was performed by materialise and the device met specifications.There was no nc identified in the dhr of this case.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: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12423490
• MDR Text Key: 271951828
• Report Number: 2939274-2021-05186
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE; UNK - PSI IMPLANTS
• Patient Sex: Male