MAUDE Adverse Event Report: SYNTHES GMBH MAXILLARY DISTRACTOR BODY 20MM; BONE PLATE

Catalog Number 288.027

Device Problem Mechanical Jam (2983)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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 history lot part number: 288.027, lot number: 13l5939, date of manufacture: 04/13/2020, place of manufacture: (b)(4), part expiration date: n/a (non sterile), list of non conformances: jbl-nr-0001612.Device history batch review of the device history records found a non-conformance report on a vended assembly (part# 288.027 lot # 13l5939) oversized feature d1 ¿ measures above specification.Found at incoming inspection operation 20.One non-conforming part was scrapped at inspection operation #20.Re-inspection of all parts for feature d1 and r1 was conducted as part of jbl-nr-0001612.6 of 25 parts passed for feature d1 and 25 of 25 parts passed for feature r1.Jb-nr-0001612 use as is technical justification was approved for feature d1.The following paragraph came from jb-nr-0001612 use as is technical justification ¿the diameter "d1" outer surface is intended to about the footplate inner diameter surface.Both diameters are highlighted below in figure a.In a worst-case scenario, a maximum oversize d1 of 5.012mm and a minimum posterior footplate dia.Of 5.02mm still allows.007 clearance between the two surfaces hence the functional requirement for interface with the posterior footplate remains intact.There are no other functional requirements that have the potential to be negatively impacted by this oos condition.¿release from hold ¿ six (6) 288.027 parts were confirmed within specification (for the d1 feature) uai ¿ eighteen (18) parts were accepted via the uai jb-nr-0001612 use as is technical justification scrap ¿ one (1) part scrapped.The worse-case part.The parts were moved on to the balance of the manufacturing operations.This non-conformance is not relevant to the complaint.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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the maxillary distractor had done for the patient for right and left sides.But two weeks later it was realized that the left side of patient¿s teeth distractor had gone back to 3mm instead of 11mm.It was unknown if any removal or revision surgery scheduled.The patient consequences were reported.This complaint involves three (3) devices.This report involves one (1) maxillary distractor body 20mm.This is report 1 of 3 for (b)(4).

• Brand Name: MAXILLARY DISTRACTOR BODY 20MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11244350
• MDR Text Key: 233451163
• Report Number: 8030965-2021-00695
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819743496
• UDI-Public: (01)07611819743496
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K020505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 288.027
• Device Lot Number: 13L5939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR