MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 212.110

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).Additional pro-code: jds.Without a valid lot number the device history records review could not be completed.Complainant device/part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporters state: (b)(6).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 that material delivered to a patient by j&j voucher was verified from the list that the 3.5 locked screws were incomplete and in varying quantities according to the size of each screw.Most of them contained only 4 units of each screw, also, a size containing only 03 units in the template, (size 28 = 3 units).Only two sizes were complete which would be a total of 6 units each.Full screws were; *screw block 3.5 x24 =6 units.*screw block 3.5x40 =6 units.The sales representative was contacted and explained the situation, he informed to me that only one locked screw was missing.The surgical schedule was a bilateral procedure and that the issue of having only 4 units of each size could impact the surgery as it was a bilateral procedure and needed more of each size.When the team arrived at the operating room, the surgeon was informed of the number of screws available in the template, according to each size.The surgeon was not pleased and expressed his frustration.It was also reported that for this reason, he decided not to go through the operation of the left hip of the patient.The surgery was performed on the patient's right side only.If possible, standardize all of these screw templates with the same amount of screws, which would be 06 units of each.This way, future problems may be avoided with new 3.5 blocked screws shortages, specifically in surgeries that are bilateral." patient status/ outcome / consequences was only one part of the surgery was done because there was not enough material to perform the second part of the body.The surgery was bilateral.This complaint involves seventy two (72) devices.This (b)(4) captures 18 devices due to the limited number of ips in a complaint.See (b)(4) for the primary complaint.This report is for 18 of the 72 devices.This complaint is 16 of 18 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 12054282
• MDR Text Key: 268246378
• Report Number: 8030965-2021-05275
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819125834
• UDI-Public: (01)07611819125834
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1