MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME LENGTHENER; LAMP, OPERATING ROOM

Catalog Number 387.338

Device Problems Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record 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

Device report from synthes reports an event in (b)(6) as follows: the newly bought synframe extension cannot be connected to the synframe ring which is already available at the hospital.Issue was noted during assembly.One of the dark blue holding sockets (387.346) could not be adjusted.As a result of this the tightening of the guide arm (387.343) was not possible.No surgery was affected and no patient involvement.Concomitant device reported: unknown synframe half ring (part# unknown; lot# unknown; quantity: 1) this complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

Event Description

Concomitant device reported: synframe guid-tube (part# 387.343, lot# unknown, quantity# 1).This report is 1 of 3 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.Shipped back device ¿synframe-extension f/387.336+387.337¿ 387.338 with lot number 4l53724 is in proper conditions.In the involved device instead they are positioned in reverse: component 2 (50131167) is below component 3 (50131152).Functional tests were performed on ¿synframe-extension f/387.336+387.337¿ 387.338 with lot number 4l53724 the following functional test was performed: the screw must move freely.The device passed the test performed.The complaint condition is confirmed, in fact, being wrongly assembled the device cannot be connected to the synframe ring.Device history lot part: 387.338, lot: 4l53724, manufacturing site: haegendorf, release to warehouse date: 19.June 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SYNFRAME LENGTHENER
• Type of Device: LAMP, OPERATING ROOM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9684028
• MDR Text Key: 192428337
• Report Number: 8030965-2020-00973
• Device Sequence Number: 1
• Product Code: FQP
• UDI-Device Identifier: 07611819109230
• UDI-Public: (01)07611819109230
• Combination Product (y/n): N
• PMA/PMN Number: K993314
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 387.338
• Device Lot Number: 4L53724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/10/2020
• Patient Sequence Number: 1
• Treatment: SYNFRAME GUID-TUBE F/ANGL-ROD NO. 387.34; UNK - REDUCTION/RETRACTION/DISTRACTION INST.; UNK - REDUCTION/RETRACTION/DISTRACTION INST.